Chronic Heart Failure With Reduced Systolic Function
Conditions
Keywords
heart failure, dapagliflozin, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors
Brief summary
The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function.
Detailed description
A 12-week randomized, double-blind, placebo-controlled trial to evaluate the effects of once-daily dapagliflozin 10 mg on heart failure disease-specific biomarkers (BNP and NTproBNP), symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function.
Interventions
DRUGDapagliflozin
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 New York Heart Association (NYHA) Class II or Class III heart failure (left ventricular ejection fraction ≤40% due to either ischemic or non-ischemic etiology) with reduced systolic function for at least 16 weeks prior to enrollment 2. No change in diuretic management for at least 1 week prior to enrollment 3. Brain natriuretic peptide (BNP) ≥100 pg/mL and/or N-terminal pro b-type natriuretic peptide (NTproBNP) ≥ 400 pg/mL at enrollment
Exclusion criteria
1. History of type 1 diabetes 2. Estimated glomerular filtration rate (eGFR) \< 30 at enrollment 3. Hospitalization for heart failure within the 30 days prior to enrollment 4. 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 the 30 days prior to enrollment 5. Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit 6. 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) within the 90 days after enrollment 7. Patients who are volume depleted based upon physical examination at the time of screening or randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP). | Average of Week 6 and Week 12 | Difference in the average of the 6- and 12-week mean N-terminal pro B-type natriuretic peptide (NTproBNP). |
| Percentage of Patients That Achieve a ≥ 5-point Increase in Heart Failure Disease Specific Quality of Life (Assessed Using Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)) or a ≥ 20% Decrease in NTproBNP Over 12 Weeks | Average of Week 6 and Week 12 | A composite of the percentage of patients that achieved a meaningful improvement in health status (≥5-point increase in average of 6- and 12-week KCCQ-OS) or NT-proBNP (≥20% decrease in average of 6- and 12-week NT-proBNP). The 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 KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) and a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | Average of Week 6 and Week 12 | The 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 KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points. |
| Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks. | Baseline to Week 6 and Week 12 | Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) over 12 weeks as measured at Week 6 and Week 12.The 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 KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points. |
| Change in 6 Minute Walk Score Over 12 Weeks. | Baseline to Week 6 and Week 12 | Change in 6 minute walk score over 12 weeks as measured at Week 6 and Week 12. The 6 minute walk test measures the distance in meters that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. |
| Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) | Baseline to Week 6 and Week 12 | Percentage of patients with a ≥ 5-point increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) as measured at Week 6 and Week 12. The 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 KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points. |
| Change in Hemoglobin A1c (HbA1c) Over 12 Weeks. | Baseline to Week 6 and Week 12 | Change in HbA1c over 12 weeks as measured at Week 6 and Week 12. |
| Change in Weight Over 12 Weeks | Baseline to Week 6 and Week 12 | Change in weight over 12 weeks as measured at Week 6 and Week 12. |
| Change in Systolic Blood Pressure Over 12 Weeks | Baseline to Week 6 and Week 12 | Change in systolic blood pressure over 12 weeks as measured at Week 6 and Week 12. |
| Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks. | Baseline to Week 6 and Week 12 | Change in BNP over 12 weeks as measured at Week 6 and Week 12 as measured at Week 6 and Week 12. |
| Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | Baseline to Week 6 and Week 12 | Percentage of patients with a ≥ 20% decrease in NTproBNP as measured at Week 6 and Week 12. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dapagliflozin Dapagliflozin 10 mg daily
Dapagliflozin | 131 |
| Dapagliflozin Matching Placebo Dapagliflozin matching placebo 10 mg daily
Dapagliflozin matching placebo | 132 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Dapagliflozin Matching Placebo | Dapagliflozin |
|---|---|---|---|
| 6-minute walk distance | 305 meters | 305 meters | 306 meters |
| Age, Continuous | 61.3 years STANDARD_DEVIATION 11.5 | 60.4 years STANDARD_DEVIATION 12 | 62.2 years STANDARD_DEVIATION 11 |
| Angiotensin converting enzyme inhibitor (ACEI) / Angiotensin II receptor blocker (ARB) | 156 Participants | 80 Participants | 76 Participants |
| Angiotensin receptor-neprilysin inhibitor (ARNI) | 85 Participants | 38 Participants | 47 Participants |
| Anticoagulant agent | 100 Participants | 42 Participants | 58 Participants |
| Atrial Fibrillation | 106 Participants | 49 Participants | 57 Participants |
| Body mass index | 30.6 kg/m^2 | 30.6 kg/m^2 | 30.7 kg/m^2 |
| Brain natriuretic peptide (BNP) | 269 pg/mL | 242 pg/mL | 288 pg/mL |
| Cardiac resynchronization therapy (CRT) | 68 Participants | 25 Participants | 43 Participants |
| Digoxin | 46 Participants | 21 Participants | 25 Participants |
| Dipeptidyl Pepdidase 4 (DPP4) inhibitor - among patients with type 2 diabetes | 21 Participants | 10 Participants | 11 Participants |
| Duration of Heart Failure | 7.1 years STANDARD_DEVIATION 6.3 | 7.2 years STANDARD_DEVIATION 6.8 | 7.1 years STANDARD_DEVIATION 5.8 |
| Ejection fraction | 26.4 % STANDARD_DEVIATION 8.1 | 25.7 % STANDARD_DEVIATION 8.2 | 27.2 % STANDARD_DEVIATION 8 |
| Estimated glomerular filtration rate (eGFR) | 69.1 mL/min/1.73m2 STANDARD_DEVIATION 22.2 | 71.2 mL/min/1.73m2 STANDARD_DEVIATION 23.1 | 66.9 mL/min/1.73m2 STANDARD_DEVIATION 21.1 |
| Glucagon-like peptide-1 receptor agonist (GLP-1RA ) - among patients with type 2 diabetes | 5 Participants | 1 Participants | 4 Participants |
| Heart rate | 71.9 beats per minute STANDARD_DEVIATION 12.3 | 71.8 beats per minute STANDARD_DEVIATION 11.3 | 72.2 beats per minute STANDARD_DEVIATION 12.4 |
| Hemoglobin | 13.4 g/dL STANDARD_DEVIATION 1.8 | 13.3 g/dL STANDARD_DEVIATION 1.7 | 13.5 g/dL STANDARD_DEVIATION 1.9 |
| Hemoglobin A1c | 7.2 % STANDARD_DEVIATION 1.9 | 7.3 % STANDARD_DEVIATION 2 | 7.0 % STANDARD_DEVIATION 1.8 |
| Hydralazine | 45 Participants | 26 Participants | 19 Participants |
| Insulin - among patients with type 2 diabetes | 87 Participants | 45 Participants | 42 Participants |
| Internal Cardiac Defibrillator (ICD) | 163 Participants | 75 Participants | 88 Participants |
| Ischemic heart disease | 139 Participants | 69 Participants | 70 Participants |
| Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CS) | 70.3 score on a scale STANDARD_DEVIATION 21.6 | 69.9 score on a scale STANDARD_DEVIATION 21.4 | 70.8 score on a scale STANDARD_DEVIATION 21.9 |
| Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) | 67.2 score on a scale STANDARD_DEVIATION 21.5 | 67.0 score on a scale STANDARD_DEVIATION 21.1 | 67.4 score on a scale STANDARD_DEVIATION 22 |
| Lipid-lowering agents | 211 Participants | 104 Participants | 107 Participants |
| Long-acting nitrates | 39 Participants | 22 Participants | 17 Participants |
| Loop diuretics | 225 Participants | 111 Participants | 114 Participants |
| Metformin - among patients with type 2 diabetes | 62 Participants | 33 Participants | 29 Participants |
| Mineralocorticoid receptor agonist (MRA) | 160 Participants | 84 Participants | 76 Participants |
| New York Heart Association (NYHA) Class II | 173 Participants | 82 Participants | 91 Participants |
| New York Heart Association (NYHA) Class III | 90 Participants | 50 Participants | 40 Participants |
| N-terminal pro B-type natriuretic peptide (NT-proBNP) | 1136 pg/mL | 1136 pg/mL | 1136 pg/mL |
| Previous Hospitalization for Heart Failure | 209 Participants | 108 Participants | 101 Participants |
| 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 | 99 Participants | 52 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) White | 144 Participants | 70 Participants | 74 Participants |
| Region of Enrollment United States | 263 participants | 132 participants | 131 participants |
| Sex: Female, Male Female | 70 Participants | 34 Participants | 36 Participants |
| Sex: Female, Male Male | 193 Participants | 98 Participants | 95 Participants |
| Sulfonylurea - among patients with type 2 diabetes | 35 Participants | 15 Participants | 20 Participants |
| Systolic Blood Pressure | 123.7 mm Hg STANDARD_DEVIATION 20.2 | 124.8 mm Hg STANDARD_DEVIATION 21.6 | 122.3 mm Hg STANDARD_DEVIATION 20.1 |
| Time since last hospitalization for heart failure | 1.6 years STANDARD_DEVIATION 2.7 | 1.8 years STANDARD_DEVIATION 3.1 | 1.4 years STANDARD_DEVIATION 2.3 |
| Type 2 diabetes mellitus | 166 Participants | 85 Participants | 81 Participants |
| Urine Albumin/Creatinine Ratio | 22.0 mg/g | 25.0 mg/g | 19.0 mg/g |
| β-blockers | 254 Participants | 124 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 131 | 1 / 132 |
| other Total, other adverse events | 19 / 131 | 18 / 132 |
| serious Total, serious adverse events | 32 / 131 | 31 / 132 |
Outcome results
Primary
Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP).
Difference in the average of the 6- and 12-week mean N-terminal pro B-type natriuretic peptide (NTproBNP).
Time frame: Average of 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 | Value (MEAN) |
|---|---|---|
| Dapagliflozin | Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP). | 1133 pg/dL |
| Dapagliflozin Matching Placebo | Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP). | 1191 pg/dL |
Primary
Percentage of Patients That Achieve a ≥ 5-point Increase in Heart Failure Disease Specific Quality of Life (Assessed Using Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)) or a ≥ 20% Decrease in NTproBNP Over 12 Weeks
A composite of the percentage of patients that achieved a meaningful improvement in health status (≥5-point increase in average of 6- and 12-week KCCQ-OS) or NT-proBNP (≥20% decrease in average of 6- and 12-week NT-proBNP). The 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 KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points.
Time frame: Average of 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 | Value (NUMBER) |
|---|---|---|
| Dapagliflozin | Percentage of Patients That Achieve a ≥ 5-point Increase in Heart Failure Disease Specific Quality of Life (Assessed Using Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)) or a ≥ 20% Decrease in NTproBNP Over 12 Weeks | 61.5 % of participants |
| Dapagliflozin Matching Placebo | Percentage of Patients That Achieve a ≥ 5-point Increase in Heart Failure Disease Specific Quality of Life (Assessed Using Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)) or a ≥ 20% Decrease in NTproBNP Over 12 Weeks | 50.4 % of participants |
Secondary
Change in 6 Minute Walk Score Over 12 Weeks.
Change in 6 minute walk score over 12 weeks as measured at Week 6 and Week 12. The 6 minute walk test measures the distance in meters that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
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 (MEAN) |
|---|---|---|---|
| Dapagliflozin | Change in 6 Minute Walk Score Over 12 Weeks. | 6-minute walk distance - 6 weeks | 297.1 meters |
| Dapagliflozin | Change in 6 Minute Walk Score Over 12 Weeks. | 6-minute walk distance - 12 weeks | 303.7 meters |
| Dapagliflozin Matching Placebo | Change in 6 Minute Walk Score Over 12 Weeks. | 6-minute walk distance - 12 weeks | 301.3 meters |
| Dapagliflozin Matching Placebo | Change in 6 Minute Walk Score Over 12 Weeks. | 6-minute walk distance - 6 weeks | 289.6 meters |
Secondary
Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks.
Change in BNP over 12 weeks as measured at Week 6 and Week 12 as measured at Week 6 and Week 12.
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 (MEAN) |
|---|---|---|---|
| Dapagliflozin | Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks. | BNP - week 6 | 236 pg/mL |
| Dapagliflozin | Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks. | BNP - week 12 | 228 pg/mL |
| Dapagliflozin Matching Placebo | Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks. | BNP - week 6 | 265 pg/mL |
| Dapagliflozin Matching Placebo | Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks. | BNP - week 12 | 272 pg/mL |
Secondary
Change in Hemoglobin A1c (HbA1c) Over 12 Weeks.
Change in HbA1c over 12 weeks as measured at Week 6 and Week 12.
Time frame: Baseline to Week 6 and Week 12
Population: The number analyzed may differ from the overall number analyzed due to missing data at certain timepoints for some participants.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dapagliflozin | Change in Hemoglobin A1c (HbA1c) Over 12 Weeks. | HbA1c - week 6 | 6.9 percentage of glycated hemoglobin |
| Dapagliflozin | Change in Hemoglobin A1c (HbA1c) Over 12 Weeks. | HbA1c - week 12 | 6.9 percentage of glycated hemoglobin |
| Dapagliflozin Matching Placebo | Change in Hemoglobin A1c (HbA1c) Over 12 Weeks. | HbA1c - week 6 | 7.1 percentage of glycated hemoglobin |
| Dapagliflozin Matching Placebo | Change in Hemoglobin A1c (HbA1c) Over 12 Weeks. | HbA1c - week 12 | 7.1 percentage of glycated hemoglobin |
Secondary
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks.
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) over 12 weeks as measured at Week 6 and Week 12.The 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 KCCQ overall summary score, 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 (MEAN) |
|---|---|---|---|
| Dapagliflozin | Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks. | KCCQ-OS - week 6 | 71.1 score on a scale |
| Dapagliflozin | Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks. | KCCQ-OS - week 12 | 72.6 score on a scale |
| Dapagliflozin Matching Placebo | Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks. | KCCQ-OS - week 6 | 70.1 score on a scale |
| Dapagliflozin Matching Placebo | Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks. | KCCQ-OS - week 12 | 68.9 score on a scale |
Secondary
Change in Systolic Blood Pressure Over 12 Weeks
Change in systolic blood pressure over 12 weeks as measured at Week 6 and Week 12.
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 (MEAN) |
|---|---|---|---|
| Dapagliflozin | Change in Systolic Blood Pressure Over 12 Weeks | Systolic Blood Pressure - week 6 | 119.2 mm Hg |
| Dapagliflozin | Change in Systolic Blood Pressure Over 12 Weeks | Systolic Blood Pressure - week 12 | 120.9 mm Hg |
| Dapagliflozin Matching Placebo | Change in Systolic Blood Pressure Over 12 Weeks | Systolic Blood Pressure - week 6 | 121.1 mm Hg |
| Dapagliflozin Matching Placebo | Change in Systolic Blood Pressure Over 12 Weeks | Systolic Blood Pressure - week 12 | 119.8 mm Hg |
Secondary
Change in Weight Over 12 Weeks
Change in weight over 12 weeks as measured at Week 6 and Week 12.
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 (MEAN) |
|---|---|---|---|
| Dapagliflozin | Change in Weight Over 12 Weeks | Weight - week 6 | 96.0 kg |
| Dapagliflozin | Change in Weight Over 12 Weeks | Weight - week 12 | 96.3 kg |
| Dapagliflozin Matching Placebo | Change in Weight Over 12 Weeks | Weight - week 6 | 96.6 kg |
| Dapagliflozin Matching Placebo | Change in Weight Over 12 Weeks | Weight - week 12 | 96.6 kg |
Secondary
Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
Percentage of patients with a ≥ 20% decrease in NTproBNP as measured at Week 6 and Week 12.
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) |
|---|---|---|---|
| Dapagliflozin | Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | NTproBNP decrease ≥ 20 % at Week 12 | 55 Participants |
| Dapagliflozin | Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | NTproBNP decrease ≥ 20 % at Week 6 | 43 Participants |
| Dapagliflozin Matching Placebo | Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | NTproBNP decrease ≥ 20 % at Week 6 | 42 Participants |
| Dapagliflozin Matching Placebo | Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | NTproBNP decrease ≥ 20 % at Week 12 | 37 Participants |
Secondary
Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)
Percentage of patients with a ≥ 5-point increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) as measured at Week 6 and Week 12. The 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 KCCQ overall summary score, 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) |
|---|---|---|---|
| Dapagliflozin | Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) | Week 6 - Improvement in KCCQ-OS | 59 Participants |
| Dapagliflozin | Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) | Week 12 - Improvement in KCCQ-OS | 54 Participants |
| Dapagliflozin Matching Placebo | Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) | Week 6 - Improvement in KCCQ-OS | 46 Participants |
| Dapagliflozin Matching Placebo | Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) | Week 12 - Improvement in KCCQ-OS | 41 Participants |
Secondary
Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) and a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
The 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 KCCQ overall summary score, a small but clinically meaningful change is considered to be ≥ 5 points.
Time frame: Average of 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 | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dapagliflozin | Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) and a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | 20 Participants |
| Dapagliflozin Matching Placebo | Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) and a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP) | 17 Participants |