Heart Failure
Conditions
Keywords
heart failure, empagliflozin, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
Brief summary
The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, on hemodynamic parameters (pulmonary artery diastolic pressure) in patients with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic etiology) who already have a CardioMEMs device (a wireless hemodynamic monitoring system) implanted for non-study related clinical reasons.
Detailed description
A 12-week randomized, double-blind, placebo-controlled trial to explore the effects of once-daily empagliflozin 10 mg on hemodynamic parameters (pulmonary artery pressures) in patients with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic etiology) who already have a CardioMEMs device implanted for non-study related clinical reasons.
Interventions
Empagliflozin 10 mg Tab
DRUGPlacebo Oral Tablet
Empagliflozin matching placebo
Sponsors
Saint Luke's Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 119 Years
Healthy volunteers
No
Inclusion criteria
1. Established diagnosis of heart failure (for at least 16 weeks prior to the screening visit) with either preserved (LVEF\>40%) or reduced systolic function (LVEF≤40%), due to either ischemic or non-ischemic etiology, documented by an imaging modality (echocardiography, nuclear imaging, LV angiography, magnetic resonance imaging) within the past 24 months. 2. No major change in diuretic management for 48 hours prior to screening visit or 48 hours prior to randomization visit (major change defined by doubling of diuretic dose or addition of another diuretic medication) 3. New York Heart Association (NYHA) class II, III or IV heart failure symptoms at the screening and randomization visit 4. Presence of previously (≥ 2 weeks prior to screening visit) implanted CardioMEMs pulmonary artery pressure monitor for a clinical indication unrelated to the study. 5. Pulmonary artery diastolic pressure ≥ 12 mmHg at the time of the screening visit (last measurement available prior to the screening visit). 6. Ability to provide informed consent prior to initiating screening visit procedures
Exclusion criteria
1. Decompensated heart failure (hospitalization for heart failure within the 2 weeks prior to screening) or between screening and randomization 2. History of type 1 diabetes 3. Major change in diuretic management during 48 hours prior to screening visit or 48 hours prior to randomization visit. (major change defined by doubling of diuretic dose or addition of another diuretic medications) 4. Significant variability in baseline pulmonary artery diastolic pressures during screening period. Defined as changes greater than +/- 6 mmHg from average pulmonary artery diastolic pressure during week 1 of the screening phase and average pulmonary artery diastolic pressure during week 2 of the screening phase for those patients with an average baseline pulmonary artery diastolic pressure during week 1 of the screening phase of \<30 mmHg. If the average baseline pulmonary artery diastolic pressure during week 1 of the screening phase is ≥30 mmHg, then ≥20% relative change in average pulmonary diastolic pressure between week 1 and week 2 of the screening phase will be used to define significant variability. 5. Initiation of hydralazine, long-acting nitrates, beta blockers, angiotensin-converting enzyme inhibitors (ACEIs) , angiotensin II receptor blockers (ARBs) or valsartan/sacubitril in the prior 4 weeks prior to screening 6. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 at the screening visit 7. Admission for an acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 30 days prior to the screening visit. 8. Implantation of cardiac resynchronization therapy (CRT) device within the previous 90 days. 9. Implantation of the CardioMEMs device within the past 2 weeks. 10. Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy), or planned implantation of cardiac resynchronization therapy (CRT) device within the 90 days after the screening visit. 11. Participation in any interventional clinical trial (with an investigational drug or device) that is not an observational registry within the 4 weeks prior to the screening visit. 12. History of hypersensitivity to empagliflozin 13. For women of child-bearing potential: Current or planned pregnancy or currently lactating 14. Life expectancy \<1 year at the screening visit 15. Patients who are volume depleted based upon physical examination at the time of the screening or randomization visit 16. Pulmonary artery diastolic pressure \< 12 mmHg at the time of the screening visit (average of last four measurements available prior to the screening visit). 17. Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) or having received treatment with any SGLT-2 inhibitor within the 8 weeks prior to the screening visit 18. Average supine systolic BP \<90 mmHg at the screening or randomization visit 19. Current documented history of bladder cancer 20. Active Gross Hematuria 21. Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valve disease, and hypertrophic obstructive cardiomyopathy (HOCM). 22. History of heart transplant. 23. Patients on heart transplant list as 1a and 1b status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Artery Diastolic Pressure From Baseline to End of Treatment Period (Defined as Average of Pulmonary Artery Diastolic Pressure Measurements Between Weeks 8-12) Between Empagliflozin and Placebo | Baseline to average between Weeks 8-12 | Change in pulmonary artery diastolic pressure from baseline to end of treatment period (defined as average of pulmonary artery diastolic pressure measurements between weeks 8-12) between empagliflozin and placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Baseline to Weeks 1-12 | Change from baseline in pulmonary artery diastolic pressure at each interim timepoint (wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) between empagliflozin and placebo. |
| Change in Pulmonary Artery Systolic Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo. | Baseline to Week 12 | Change in pulmonary artery systolic pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo. |
| Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Baseline to Weeks 1-12 | Change from baseline in pulmonary artery systolic pressure at each interim time point (wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) between empagliflozin and placebo. |
| Change in Mean Pulmonary Artery Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo. | Baseline to Week 12 | Change in mean pulmonary artery pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo. |
| Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Baseline to Weeks 1-12 | Change from baseline in mean pulmonary artery pressure at each interim time point (weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) between empagliflozin and placebo. |
| Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Baseline to Week 6 and Week 12 | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. |
| Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | Baseline to Week 6 and Week 12 | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. |
| Change in 6 Minute Walk Test From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Baseline to Week 6 and Week 12 | Change in 6 minute walk test from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. |
| Change in Brain Natriuretic Peptide (BNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Baseline to Week 6 and Week 12 | Change in brain natriuretic peptide (BNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. |
| Proportion of Patients With a ≥ 20% Decrease From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | Baseline to Week 6 and Week 12 | Proportion of patients with a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. |
| Proportion of Patients With a ≥ 20% Decrease From Baseline in Brain Natriuretic Peptide (BNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | Baseline to Week 6 and Week 12 | Proportion of patients with a ≥ 20% decrease from baseline in brain natriuretic peptide (BNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. |
| Proportion of Patients With Both a ≥ 5 Point Increase From Baseline in KCCQ-OS and a ≥ 20% Decrease From Baseline in NT-proBNP at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | Baseline to Week 6 and Week 12 | Proportion of patients with both a ≥ 5 point increase from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) and a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. |
| Number of Participants With Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo | Baseline to Week 12 | Number of Participants with Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo |
| Change in Hemoglobin A1c From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Baseline to Week 6 and Week 12 | Change in Hemoglobin A1c from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. |
| Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Baseline to Week 6 and Week 12 | Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Empagliflozin Empagliflozin 10 mg tab, once daily, for 12 weeks
Empagliflozin 10 mg Tab: Empagliflozin 10 mg Tab | 33 |
| Placebo Empagliflozin matching placebo oral tablet, once daily for 12 weeks
Placebo Oral Tablet: Empagliflozin matching placebo | 32 |
| Total | 65 |
Baseline characteristics
| Characteristic | Empagliflozin | Placebo | Total |
|---|---|---|---|
| 6-minute walk distance | 237.7 meters | 232.1 meters | 233.2 meters |
| Age, Continuous | 69.5 years STANDARD_DEVIATION 12 | 62.9 years STANDARD_DEVIATION 13.3 | 66.2 years STANDARD_DEVIATION 12.9 |
| Angiotensin-converting enzyme inhibitor / Angiotensin II receptor blocker (ACEI/ARB) | 11 Participants | 8 Participants | 19 Participants |
| Angiotensin receptor-neprilysin inhibitor (ARNI) | 13 Participants | 17 Participants | 30 Participants |
| Anticoagulant agent | 16 Participants | 13 Participants | 29 Participants |
| Atrial Fibrillation | 20 Participants | 17 Participants | 37 Participants |
| Beta blockers | 29 Participants | 29 Participants | 58 Participants |
| Body Mass Index | 33.5 kg/m^2 | 33.8 kg/m^2 | 33.5 kg/m^2 |
| Brain natriuretic peptide (BNP) | 140.0 pg/mL | 129.0 pg/mL | 140 pg/mL |
| Cardiac resynchronization therapy (CRT) | 13 Participants | 8 Participants | 21 Participants |
| Digoxin | 6 Participants | 3 Participants | 9 Participants |
| Dipeptidyl-peptidase 4 (DPP4) inhibitor (among patients with type 2 diabetes) | 2 Participants | 2 Participants | 4 Participants |
| Duration of Heart Failure | 5.4 years STANDARD_DEVIATION 5.7 | 7.2 years STANDARD_DEVIATION 5.5 | 6.3 years STANDARD_DEVIATION 5.6 |
| Ejection fraction | 46.7 % STANDARD_DEVIATION 14.9 | 40.7 % STANDARD_DEVIATION 17.2 | 43.7 % STANDARD_DEVIATION 16.2 |
| Estimated glomerular filtration rate (eGFR) | 51.2 mL/min/1.73m^2 STANDARD_DEVIATION 19.7 | 62.7 mL/min/1.73m^2 STANDARD_DEVIATION 25.5 | 56.9 mL/min/1.73m^2 STANDARD_DEVIATION 23.3 |
| Glucagon-like peptide-1 receptor agonist (GLP-1 RA )(among patients with type 2 diabetes) | 3 Participants | 4 Participants | 7 Participants |
| Heart rate | 70.1 bpm STANDARD_DEVIATION 10.2 | 72.6 bpm STANDARD_DEVIATION 9.8 | 71.3 bpm STANDARD_DEVIATION 10 |
| Hemoglobin | 13.3 g/dL STANDARD_DEVIATION 2.1 | 12.5 g/dL STANDARD_DEVIATION 1.6 | 12.9 g/dL STANDARD_DEVIATION 1.9 |
| Hemoglobin A1c (HbA1c) | 6.4 percentage of hemoglobin STANDARD_DEVIATION 1.3 | 6.9 percentage of hemoglobin STANDARD_DEVIATION 1.9 | 6.6 percentage of hemoglobin STANDARD_DEVIATION 1.6 |
| Hydralazine | 7 Participants | 3 Participants | 10 Participants |
| Implantable cardioverter defibrillator (ICD) | 15 Participants | 21 Participants | 36 Participants |
| Insulin (among patients with type 2 diabetes) | 11 Participants | 11 Participants | 22 Participants |
| Ischemic heart disease | 13 Participants | 10 Participants | 23 Participants |
| Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CS) | 60.2 points STANDARD_DEVIATION 18.7 | 64.6 points STANDARD_DEVIATION 26.4 | 62.4 points STANDARD_DEVIATION 22.8 |
| Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) | 60.5 points STANDARD_DEVIATION 16.9 | 61.1 points STANDARD_DEVIATION 27.2 | 60.8 points STANDARD_DEVIATION 22.4 |
| Lipid lowering agent | 27 Participants | 23 Participants | 50 Participants |
| Long-acting nitrates | 15 Participants | 9 Participants | 24 Participants |
| Loop diuretics | 31 Participants | 32 Participants | 63 Participants |
| Mineralocorticoid receptor antagonist (MRA) | 9 Participants | 20 Participants | 29 Participants |
| New York Heart Association (NYHA) Class II | 14 Participants | 16 Participants | 30 Participants |
| New York Heart Association (NYHA) Class III | 18 Participants | 16 Participants | 34 Participants |
| N-terminal pro b-type natriuretic peptide (NT-proBNP) | 865.5 pg/mL | 563.5 pg/mL | 637.0 pg/mL |
| Prior hospitalization for heart failure | 29 Participants | 28 Participants | 57 Participants |
| Pulmonary Artery Diastolic Pressure | 23.3 mm Hg STANDARD_DEVIATION 6.9 | 20.5 mm Hg STANDARD_DEVIATION 5.7 | 21.9 mm Hg STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 27 Participants | 23 Participants | 50 Participants |
| Region of Enrollment United States | 33 participants | 32 participants | 65 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 21 Participants | 20 Participants | 41 Participants |
| Sulfonylurea (among patients with type 2 diabetes) | 2 Participants | 1 Participants | 3 Participants |
| Systolic Blood Pressure | 128.3 mm Hg STANDARD_DEVIATION 19.1 | 120.7 mm Hg STANDARD_DEVIATION 20.3 | 124.5 mm Hg STANDARD_DEVIATION 19.9 |
| Time since last hospitalization for heart failure | 1.3 years STANDARD_DEVIATION 0.9 | 1.5 years STANDARD_DEVIATION 1.4 | 1.4 years STANDARD_DEVIATION 1.2 |
| Type 2 Diabetes | 18 Participants | 16 Participants | 34 Participants |
| Urine Albumin/Creatinine Ratio | 101.9 mg/g STANDARD_DEVIATION 187.4 | 201.6 mg/g STANDARD_DEVIATION 688.2 | 149.3 mg/g STANDARD_DEVIATION 491.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 33 | 0 / 32 |
| other Total, other adverse events | 19 / 33 | 16 / 32 |
| serious Total, serious adverse events | 8 / 33 | 9 / 32 |
Outcome results
Primary
Change in Pulmonary Artery Diastolic Pressure From Baseline to End of Treatment Period (Defined as Average of Pulmonary Artery Diastolic Pressure Measurements Between Weeks 8-12) Between Empagliflozin and Placebo
Change in pulmonary artery diastolic pressure from baseline to end of treatment period (defined as average of pulmonary artery diastolic pressure measurements between weeks 8-12) between empagliflozin and placebo
Time frame: Baseline to average between Weeks 8-12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Empagliflozin | Change in Pulmonary Artery Diastolic Pressure From Baseline to End of Treatment Period (Defined as Average of Pulmonary Artery Diastolic Pressure Measurements Between Weeks 8-12) Between Empagliflozin and Placebo | 20.7 mm Hg |
| Placebo | Change in Pulmonary Artery Diastolic Pressure From Baseline to End of Treatment Period (Defined as Average of Pulmonary Artery Diastolic Pressure Measurements Between Weeks 8-12) Between Empagliflozin and Placebo | 22.2 mm Hg |
Secondary
Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo.
Change from baseline in mean pulmonary artery pressure at each interim time point (weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) between empagliflozin and placebo.
Time frame: Baseline to Weeks 1-12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 12 | 29.3 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 0 | 30.1 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 1 | 30.1 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 2 | 30.1 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 3 | 30.0 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 4 | 30.0 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 5 | 30.0 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 6 | 30.0 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 7 | 29.9 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 8 | 29.9 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 9 | 29.8 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 10 | 29.6 mm Hg |
| Empagliflozin | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 11 | 29.5 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 9 | 31.1 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 6 | 30.9 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 0 | 30.1 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 11 | 31.1 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 1 | 30.2 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 7 | 31.0 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 2 | 30.4 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 10 | 31.1 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 3 | 30.5 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 8 | 31.1 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 4 | 30.7 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 12 | 31.1 mm Hg |
| Placebo | Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo. | Pulmonary artery pressure - Week 5 | 30.8 mm Hg |
Secondary
Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo.
Change from baseline in pulmonary artery diastolic pressure at each interim timepoint (wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) between empagliflozin and placebo.
Time frame: Baseline to Weeks 1-12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 2 | 21.1 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 7 | 21.0 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 4 | 21.0 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 8 | 21.0 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 1 | 21.2 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 9 | 20.8 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 5 | 21.0 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 10 | 20.7 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 3 | 21.1 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 11 | 20.5 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 6 | 21.0 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 12 | 20.4 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 0 | 21.2 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 12 | 22.1 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 0 | 21.4 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 1 | 21.5 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 2 | 21.7 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 3 | 21.8 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 4 | 21.9 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 5 | 22.0 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 6 | 22.1 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 7 | 22.1 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 8 | 22.2 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 9 | 22.2 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 10 | 22.2 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo. | Pulmonary artery diastolic pressure - Week 11 | 22.2 mm Hg |
Secondary
Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo.
Change from baseline in pulmonary artery systolic pressure at each interim time point (wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) between empagliflozin and placebo.
Time frame: Baseline to Weeks 1-12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 2 | 44.1 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 7 | 43.8 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 4 | 44.0 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 8 | 43.7 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 1 | 44.1 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 9 | 43.6 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 5 | 44.0 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 10 | 43.4 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 3 | 44.1 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 11 | 43.3 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 6 | 44.0 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 12 | 43.1 mm Hg |
| Empagliflozin | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 0 | 44.1 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 12 | 44.9 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 0 | 43.9 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 1 | 44.0 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 2 | 44.1 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 3 | 44.2 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 4 | 44.3 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 5 | 44.4 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 6 | 44.6 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 7 | 44.7 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 8 | 44.8 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 9 | 44.9 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 10 | 44.9 mm Hg |
| Placebo | Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo. | Pulmonary artery systolic pressure - Week 11 | 44.9 mm Hg |
Secondary
Change in 6 Minute Walk Test From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
Change in 6 minute walk test from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Empagliflozin | Change in 6 Minute Walk Test From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | 6-minute walk distance - 6 weeks | 202.5 meters |
| Empagliflozin | Change in 6 Minute Walk Test From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | 6-minute walk distance - 12 weeks | 217.4 meters |
| Placebo | Change in 6 Minute Walk Test From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | 6-minute walk distance - 6 weeks | 211.2 meters |
| Placebo | Change in 6 Minute Walk Test From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | 6-minute walk distance - 12 weeks | 174.7 meters |
Secondary
Change in Brain Natriuretic Peptide (BNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
Change in brain natriuretic peptide (BNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Empagliflozin | Change in Brain Natriuretic Peptide (BNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | BNP - 6 weeks | 143 pg/mL |
| Empagliflozin | Change in Brain Natriuretic Peptide (BNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | BNP - 12 weeks | 144 pg/mL |
| Placebo | Change in Brain Natriuretic Peptide (BNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | BNP - 6 weeks | 149 pg/mL |
| Placebo | Change in Brain Natriuretic Peptide (BNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | BNP - 12 weeks | 167 pg/mL |
Secondary
Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.
Time frame: Baseline to Week 6 and Week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Empagliflozin | Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) score - 6 weeks | 63.5 score on a scale |
| Empagliflozin | Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) score - 12 weeks | 64.2 score on a scale |
| Empagliflozin | Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) score - 6 weeks | 66.6 score on a scale |
| Empagliflozin | Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) score - 12 weeks | 65.8 score on a scale |
| Placebo | Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) score - 12 weeks | 60.2 score on a scale |
| Placebo | Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) score - 6 weeks | 66.6 score on a scale |
| Placebo | Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) score - 6 weeks | 65.6 score on a scale |
| Placebo | Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) score - 12 weeks | 61.7 score on a scale |
Secondary
Change in Hemoglobin A1c From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
Change in Hemoglobin A1c from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Empagliflozin | Change in Hemoglobin A1c From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Hemoglobin A1c - 6 weeks | 6.6 percentage of hemoglobin |
| Empagliflozin | Change in Hemoglobin A1c From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Hemoglobin A1c - 12 weeks | 6.8 percentage of hemoglobin |
| Placebo | Change in Hemoglobin A1c From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Hemoglobin A1c - 6 weeks | 6.5 percentage of hemoglobin |
| Placebo | Change in Hemoglobin A1c From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | Hemoglobin A1c - 12 weeks | 6.3 percentage of hemoglobin |
Secondary
Change in Mean Pulmonary Artery Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo.
Change in mean pulmonary artery pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo.
Time frame: Baseline to Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Empagliflozin | Change in Mean Pulmonary Artery Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo. | 29.3 mm Hg |
| Placebo | Change in Mean Pulmonary Artery Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo. | 31.1 mm Hg |
Secondary
Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Empagliflozin | Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | NT-proBNP - 6 weeks | 693 pg/mL |
| Empagliflozin | Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | NT-proBNP - 12 weeks | 659 pg/mL |
| Placebo | Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | NT-proBNP - 6 weeks | 655 pg/mL |
| Placebo | Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo. | NT-proBNP - 12 weeks | 802 pg/mL |
Secondary
Change in Pulmonary Artery Systolic Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo.
Change in pulmonary artery systolic pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo.
Time frame: Baseline to Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Empagliflozin | Change in Pulmonary Artery Systolic Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo. | 20.4 mm Hg |
| Placebo | Change in Pulmonary Artery Systolic Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo. | 22.1 mm Hg |
Secondary
Number of Participants With Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo
Number of Participants with Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo
Time frame: Baseline to Week 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Empagliflozin | Number of Participants With Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo | Number of patients with no loop diuretic changes | 25 Participants |
| Empagliflozin | Number of Participants With Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo | Number of patients with loop diuretic changes | 8 Participants |
| Placebo | Number of Participants With Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo | Number of patients with no loop diuretic changes | 26 Participants |
| Placebo | Number of Participants With Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo | Number of patients with loop diuretic changes | 6 Participants |
Secondary
Proportion of Patients With a ≥ 20% Decrease From Baseline in Brain Natriuretic Peptide (BNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
Proportion of patients with a ≥ 20% decrease from baseline in brain natriuretic peptide (BNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12
Population: The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Empagliflozin | Proportion of Patients With a ≥ 20% Decrease From Baseline in Brain Natriuretic Peptide (BNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | BNP decrease >/= 20% - 6 weeks | 12 Participants |
| Empagliflozin | Proportion of Patients With a ≥ 20% Decrease From Baseline in Brain Natriuretic Peptide (BNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | BNP decrease >/= 20% - 12 weeks | 11 Participants |
| Placebo | Proportion of Patients With a ≥ 20% Decrease From Baseline in Brain Natriuretic Peptide (BNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | BNP decrease >/= 20% - 12 weeks | 4 Participants |
| Placebo | Proportion of Patients With a ≥ 20% Decrease From Baseline in Brain Natriuretic Peptide (BNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | BNP decrease >/= 20% - 6 weeks | 6 Participants |
Secondary
Proportion of Patients With a ≥ 20% Decrease From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
Proportion of patients with a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12
Population: The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Empagliflozin | Proportion of Patients With a ≥ 20% Decrease From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | NT-proBNP decrease >/= 20% - 6 weeks | 10 Participants |
| Empagliflozin | Proportion of Patients With a ≥ 20% Decrease From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | NT-proBNP decrease >/= 20% - 12 weeks | 11 Participants |
| Placebo | Proportion of Patients With a ≥ 20% Decrease From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | NT-proBNP decrease >/= 20% - 6 weeks | 6 Participants |
| Placebo | Proportion of Patients With a ≥ 20% Decrease From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | NT-proBNP decrease >/= 20% - 12 weeks | 2 Participants |
Secondary
Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.
Time frame: Baseline to Week 6 and Week 12
Population: The number of participants analyzed may differ from the overall number of participants analyzed due to missing data at certain timepoints for some participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Empagliflozin | Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | KCCQ-OS score increase >/= 5 points (6 weeks) | 13 Participants |
| Empagliflozin | Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | KCCQ-OS score increase >/= 5 points (12 weeks) | 11 Participants |
| Empagliflozin | Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | KCCQ-CS score increase >/= 5 points (6 weeks) | 13 Participants |
| Empagliflozin | Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | KCCQ-CS score increase >/= 5 points (12 weeks) | 12 Participants |
| Placebo | Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | KCCQ-CS score increase >/= 5 points (12 weeks) | 5 Participants |
| Placebo | Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | KCCQ-OS score increase >/= 5 points (6 weeks) | 15 Participants |
| Placebo | Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | KCCQ-CS score increase >/= 5 points (6 weeks) | 10 Participants |
| Placebo | Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | KCCQ-OS score increase >/= 5 points (12 weeks) | 10 Participants |
Secondary
Proportion of Patients With Both a ≥ 5 Point Increase From Baseline in KCCQ-OS and a ≥ 20% Decrease From Baseline in NT-proBNP at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
Proportion of patients with both a ≥ 5 point increase from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) and a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.
Time frame: Baseline to Week 6 and Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Empagliflozin | Proportion of Patients With Both a ≥ 5 Point Increase From Baseline in KCCQ-OS and a ≥ 20% Decrease From Baseline in NT-proBNP at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | 19 Participants |
| Placebo | Proportion of Patients With Both a ≥ 5 Point Increase From Baseline in KCCQ-OS and a ≥ 20% Decrease From Baseline in NT-proBNP at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo. | 14 Participants |