Acute Heart Failure
Conditions
Brief summary
The primary objective is to test the hypothesis that, compared with placebo, therapy with Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge period will be associated with greater clinical stability at six months as assessed by a composite clinical endpoint.
Detailed description
Hospitalization for AHFS identifies individuals at increased risk of death and re-hospitalization following discharge. This increased risk justifies intervention with novel therapy during the vulnerable post-discharge period to enhance clinical stability and prevent early HF mortality and readmissions. As heart failure (HF) progresses, impairments in metabolism render the heart substrate constrained, limiting cardiac metabolism. Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin peptide that enhances cellular glucose uptake by stimulating insulin secretion and insulin sensitivity in target tissues. Preclinical and early-phase clinical data support GLP-1 as an effective therapy for advanced HF while use of GLP-1 receptor agonists in large numbers of patients with diabetes reveal a good safety profile and reductions in adverse cardiac outcomes.
Interventions
DRUGLiraglutide
Active Drug
DRUGPlacebo
Placebo
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. AHFS as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography) 3. AHFS is the primary cause of hospitalization 4. Prior clinical diagnosis of HF 5. Left Ventricular Ejection Fraction(LVEF) ≤ 40% during the preceding 3 months (if no echo within the preceding 3 months, an LVEF ≤ 30% during the preceding three years is acceptable) 6. On evidence-based medication for HF (including beta-blocker and ACE-inhibitor/ARB) or previously deemed intolerant 7. Use of at least 80 mg or furosemide total daily dose (or equivalent) prior to admission for AHFS (a lower dose of a loop diuretic combined with a thiazide will count as an equivalent) 8. Willingness to provide informed consent
Exclusion criteria
1. AHFS due to acute myocarditis or acute Myocardial Infarction 2. Ongoing hemodynamically significant arrhythmias contributing to HF decompensation 3. Inotrope, intra-aortic balloon pump (IABP) or other mechanical circulatory support use at the time of consent. Prior use will not exclude a patient. 4. Current or planned left ventricular assist device therapy in next 180 days 5. United Network for Organ Sharing status 1A or 1B 6. B-type natriuretic peptide(BNP)\< 250 or NT-proBNP\<1,000 (Not required per protocol but if available and too low would be an exclusion; within 48 hours of consent) 7. Hemoglobin (Hgb) \< 8.0 g/dl 8. Glomerular filtration rate(GFR) \< 20 ml/min/1.73 m2 within 48 hours of consent 9. Systolic blood pressure \< 80 mmHg at consent 10. Resting Heart Rate \> 110 at consent 11. Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) changes and biomarkers of myocardial necrosis (e.g. troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent) 12. Percutaneous Coronary Intervention, coronary artery bypass grafting or new biventricular pacing within past 4 weeks 13. Primary hypertrophic cardiomyopathy 14. Infiltrative cardiomyopathy 15. Constrictive pericarditis or tamponade 16. Complex congenital heart disease 17. Non-cardiac pulmonary edema 18. More than moderate aortic or mitral stenosis 19. Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation 20. Sepsis, active infection (excluding cystitis) or other comorbidity driving the HF decompensation 21. Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, International Normalized Ration (INR) \> 1.7 in the absence of anticoagulation treatment 22. Terminal illness (other than HF) with expected survival of less than 1 year 23. Previous adverse reaction to the study drug 24. Receipt of any investigational product in the previous 30 days. 25. Enrollment or planned enrollment in another randomized therapeutic clinical trial in next 6 months. 26. Inability to comply with planned study procedures 27. Pregnancy or breastfeeding mothers 28. Women of reproductive age not on adequate contraception 29. History of acute or chronic pancreatitis 30. History of symptomatic gastroparesis 31. Familial or personal history of medullary thyroid cancer or multiple endocrine neoplasia type-2 (MEN2) 32. Prior weight-loss surgery (i.e., Roux-en-Y gastric bypass) or other gastric surgery associated with increased endogenous GLP-1 production 33. Prior or ongoing treatment with GLP-1 receptor agonists 34. Ongoing treatment with dipeptidyl peptide-IV inhibitors (1 week washout required) 35. Ongoing treatment with thiazolidinedione 36. Oxygen-dependent chronic obstructive pulmonary disease 37. Diabetic patients with history of 2 or more severe hypoglycemia, Diabetic Ketoacidosis(DKA) or hyperglycemic, hyperosmotic nonketotic coma in the preceding 12 months. 38. Diagnosis of Type 1 Diabetes Mellitus 40\. If diabetic, inadequate glycemic control with glucose level \> 300 mg/dL within 24 hours of randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Ranking of Predefined Events | Randomization to 180 days | A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular End-systolic Volume Index | Baseline to 180 days | Change in left ventricular end-systolic volume index from baseline to day 180. |
| Change in Left Ventricular Ejection Fraction | Baseline to 180 days | Change in left ventricular ejection fraction from baseline to day 180 |
| Change in Medial Filling Pressure | Baseline to 180 days | Change in medial filling pressure baseline to day 180. |
| Change in Lateral Filling Pressure | Baseline to 180 days | Change in lateral filling pressure baseline to day 180. |
| Change in 6 Minute Walk Distance | Baseline to day 30 | Change in 6 minute walk distance baseline to day 30 |
| Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline to 30 days | Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
| Change in Left Ventricular End-Diastolic Volume Index | Baseline to 180 days | Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days. |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. | Baseline to 180 days | Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
| Individual Component of the Primary Endpoint- Mortality | Randomization to 180 days | Individual component of the primary endpoint of mortality at 180 days after randomization |
| Individual Component of the Primary Endpoint- Heart Failure Hospitalization | Randomization to 180 days | Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days |
| Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP | Baseline to 180 days | Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days |
| Global Ranking of Predefined Events | Baseline to 180 days | A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation. |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Baseline to 30 days | Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liraglutide Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.
Liraglutide: Active Drug | 154 |
| Placebo Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.
Placebo: Placebo | 146 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 23 | 16 |
| Overall Study | Lost to Follow-up | 5 | 7 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 9 |
Baseline characteristics
| Characteristic | Placebo | Total | Liraglutide |
|---|---|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 12.2 | 59.7 years STANDARD_DEVIATION 12.5 | 59.9 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 15 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 135 Participants | 285 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants | 115 Participants | 67 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 90 Participants | 172 Participants | 82 Participants |
| Sex: Female, Male Female | 33 Participants | 64 Participants | 31 Participants |
| Sex: Female, Male Male | 113 Participants | 236 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 33 / 154 | 33 / 146 |
Outcome results
Primary
Global Ranking of Predefined Events
A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size.
Time frame: Randomization to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Global Ranking of Predefined Events | 145.5 rank | Standard Deviation 88.1 |
| Placebo | Global Ranking of Predefined Events | 155.7 rank | Standard Deviation 85.3 |
p-value: 0.3087Rank score
Secondary
Change in 6 Minute Walk Distance
Change in 6 minute walk distance baseline to 90 days.
Time frame: Baseline to 90 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in 6 Minute Walk Distance | 56.8 meters | Standard Deviation 132.7 |
| Placebo | Change in 6 Minute Walk Distance | 38.7 meters | Standard Deviation 115.4 |
p-value: 0.1309Regression, Linear
Secondary
Change in 6 Minute Walk Distance
Change in 6 minute walk distance baseline to 180 days.
Time frame: Baseline to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in 6 Minute Walk Distance | 55.7 meters | Standard Deviation 133.9 |
| Placebo | Change in 6 Minute Walk Distance | 55.3 meters | Standard Deviation 127.2 |
p-value: 0.792Regression, Linear
Secondary
Change in 6 Minute Walk Distance
Change in 6 minute walk distance baseline to day 30
Time frame: Baseline to day 30
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in 6 Minute Walk Distance | 50.4 meters | Standard Deviation 110.8 |
| Placebo | Change in 6 Minute Walk Distance | 37.3 meters | Standard Deviation 99.6 |
p-value: 0.1705Regression, Linear
Secondary
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline to 90 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 13.86 units on a scale | Standard Deviation 24.99 |
| Placebo | Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 11.72 units on a scale | Standard Deviation 23.82 |
p-value: 0.2662Regression, Linear
Secondary
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline to 30 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 14.69 units on a scale | Standard Deviation 25.9 |
| Placebo | Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 14.44 units on a scale | Standard Deviation 22.03 |
p-value: 0.7026Regression, Linear
Secondary
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to day 180.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline to day 180
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 13.79 units on a scale | Standard Deviation 23.83 |
| Placebo | Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 13.14 units on a scale | Standard Deviation 23.6 |
p-value: 0.6395Regression, Linear
Secondary
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline to 30 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | 12.98 units on a scale | Standard Deviation 23.82 |
| Placebo | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | 14.01 units on a scale | Standard Deviation 20.09 |
p-value: 0.8218Regression, Linear
Secondary
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline to 90 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | 14.17 units on a scale | Standard Deviation 24.46 |
| Placebo | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | 10.62 units on a scale | Standard Deviation 22.48 |
p-value: 0.1124Regression, Linear
Secondary
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.
Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. | 13.44 units on a scale | Standard Deviation 22.61 |
| Placebo | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. | 13.25 units on a scale | Standard Deviation 22.38 |
p-value: 0.8088Regression, Linear
Secondary
Change in Lateral Filling Pressure
Change in lateral filling pressure baseline to day 180.
Time frame: Baseline to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in Lateral Filling Pressure | -0.05 m/sec | Standard Deviation 12.3 |
| Placebo | Change in Lateral Filling Pressure | 0.39 m/sec | Standard Deviation 13.1 |
p-value: 0.4266Regression, Linear
Secondary
Change in Left Ventricular Ejection Fraction
Change in left ventricular ejection fraction from baseline to day 180
Time frame: Baseline to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in Left Ventricular Ejection Fraction | 1.07 percent | Standard Deviation 9.1 |
| Placebo | Change in Left Ventricular Ejection Fraction | 1.37 percent | Standard Deviation 10 |
p-value: 0.9535Regression, Linear
Secondary
Change in Left Ventricular End-Diastolic Volume Index
Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days.
Time frame: Baseline to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in Left Ventricular End-Diastolic Volume Index | 3.37 ml per meter squared | Standard Deviation 31.9 |
| Placebo | Change in Left Ventricular End-Diastolic Volume Index | -2.91 ml per meter squared | Standard Deviation 32.04 |
p-value: 0.1549Regression, Linear
Secondary
Change in Left Ventricular End-systolic Volume Index
Change in left ventricular end-systolic volume index from baseline to day 180.
Time frame: Baseline to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in Left Ventricular End-systolic Volume Index | 1.16 ml per meter squared | Standard Deviation 26.2 |
| Placebo | Change in Left Ventricular End-systolic Volume Index | -3.47 ml per meter squared | Standard Deviation 26.5 |
p-value: 0.1932Regression, Linear
Secondary
Change in Medial Filling Pressure
Change in medial filling pressure baseline to day 180.
Time frame: Baseline to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Change in Medial Filling Pressure | 1.12 m/sec | Standard Deviation 18.8 |
| Placebo | Change in Medial Filling Pressure | 0.25 m/sec | Standard Deviation 17.8 |
p-value: 0.8548Regression, Linear
Secondary
Global Ranking of Predefined Events
A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation.
Time frame: Baseline to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Global Ranking of Predefined Events | 144.29 rank | Standard Deviation 87.63 |
| Placebo | Global Ranking of Predefined Events | 157.05 rank | Standard Deviation 85.61 |
p-value: 0.2033Rank score
Secondary
Individual Component of the Primary Endpoint- Heart Failure Hospitalization
Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days
Time frame: Randomization to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide | Individual Component of the Primary Endpoint- Heart Failure Hospitalization | 63 participants |
| Placebo | Individual Component of the Primary Endpoint- Heart Failure Hospitalization | 50 participants |
p-value: 0.1701Log Rank
Secondary
Individual Component of the Primary Endpoint- Mortality
Individual component of the primary endpoint of mortality at 180 days after randomization
Time frame: Randomization to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide | Individual Component of the Primary Endpoint- Mortality | 19 participants |
| Placebo | Individual Component of the Primary Endpoint- Mortality | 16 participants |
p-value: 0.7764Log Rank
Secondary
Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP
Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days
Time frame: Baseline to 180 days
Population: All randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP | 335.81 weighted average of ratio to baseline | Standard Deviation 445.8 |
| Placebo | Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP | 317 weighted average of ratio to baseline | Standard Deviation 307.64 |
p-value: 0.6532Regression, Linear