Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5U10HL084904-09 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Active Comparator | Increasing dose from 0.6mg, 1.2mg to 1.8mg SQ daily. |
|
| Placebo | Placebo Comparator | Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg SQ daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Active Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Randomization to 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular End-Diastolic Volume Index | Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days. | Baseline to 180 days |
| Change in Left Ventricular End-systolic Volume Index |
Not provided
Inclusion Criteria:
Exclusion Criteria:
40. If diabetic, inadequate glycemic control with glucose level > 300 mg/dL within 24 hours of randomization
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian Hernandez, MD | Duke University | Principal Investigator |
| Eugene Bruanwald, MD | Harvard University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Services | Newark | Delaware | 19718 | United States | ||
| Emory University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35654972 | Derived | Lerman JB, Giamberardino SN, Hernandez AF, Felker GM, Shah SH, McGarrah RW. Plasma metabolites associated with functional and clinical outcomes in heart failure with reduced ejection fraction with and without type 2 diabetes. Sci Rep. 2022 Jun 2;12(1):9183. doi: 10.1038/s41598-022-12973-0. | |
| 32362166 | Derived | Redouane B, Greene SJ, Fudim M, Vaduganathan M, Ambrosy AP, Sun JL, DeVore AD, McNulty SE, Mentz RJ, Hernandez AF, Felker GM, Cooper LB, Borlaug BA, Velazquez EJ, Margulies KB, Sharma A. Effects of Liraglutide on Worsening Renal Function Among Patients With Heart Failure With Reduced Ejection Fraction: Insights From the FIGHT Trial. Circ Heart Fail. 2020 May;13(5):e006758. doi: 10.1161/CIRCHEARTFAILURE.119.006758. Epub 2020 May 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide | Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily. Liraglutide: Active Drug |
| FG001 | Placebo | Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily. Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo |
|
Change in left ventricular end-systolic volume index from baseline to day 180.
| Baseline to 180 days |
| Change in Left Ventricular Ejection Fraction | Change in left ventricular ejection fraction from baseline to day 180 | Baseline to 180 days |
| Change in Medial Filling Pressure | Change in medial filling pressure baseline to day 180. | Baseline to 180 days |
| Change in Lateral Filling Pressure | Change in lateral filling pressure baseline to day 180. | Baseline to 180 days |
| Change in 6 Minute Walk Distance | Change in 6 minute walk distance baseline to day 30 | Baseline to day 30 |
| Change in 6 Minute Walk Distance | Change in 6 minute walk distance baseline to 90 days. | Baseline to 90 days |
| Change in 6 Minute Walk Distance | Change in 6 minute walk distance baseline to 180 days. | Baseline to 180 days |
| 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. | Baseline to 30 days |
| 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. | Baseline to 90 days |
| 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. | Baseline to day 180 |
| 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. | Baseline to 30 days |
| 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. | Baseline to 90 days |
| 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. | Baseline to 180 days |
| Individual Component of the Primary Endpoint- Mortality | Individual component of the primary endpoint of mortality at 180 days after randomization | Randomization to 180 days |
| Individual Component of the Primary Endpoint- Heart Failure Hospitalization | Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days | Randomization to 180 days |
| 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 | Baseline to 180 days |
| 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. | Baseline to 180 days |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston VA Healtcare System | West Roxbury | Massachusetts | 02132 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Saint Louis University Hospital | St Louis | Missouri | 63117 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Southeast Regional Medical Center | Lumberton | North Carolina | 28538 | United States |
| University Hospitals- Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Metro Health System | Cleveland | Ohio | 44109 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Lancaster Heart and Stroke Foundation | Lancaster | Pennsylvania | 17603 | United States |
| University of Pennsylvaina | Philadelphia | Pennsylvania | 19104 | United States |
| Jefferson Medical College | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Michael Debakey VA Medical Center | Houston | Texas | 77030 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | United States |
| Utah VA Medical Center | Salt Lake City | Utah | 84132 | United States |
| The University of Vermont- Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
| 30120812 | Derived | Sharma A, Ambrosy AP, DeVore AD, Margulies KB, McNulty SE, Mentz RJ, Hernandez AF, Michael Felker G, Cooper LB, Lala A, Vader J, Groake JD, Borlaug BA, Velazquez EJ. Liraglutide and weight loss among patients with advanced heart failure and a reduced ejection fraction: insights from the FIGHT trial. ESC Heart Fail. 2018 Dec;5(6):1035-1043. doi: 10.1002/ehf2.12334. Epub 2018 Aug 17. |
| 27483064 | Derived | Margulies KB, Hernandez AF, Redfield MM, Givertz MM, Oliveira GH, Cole R, Mann DL, Whellan DJ, Kiernan MS, Felker GM, McNulty SE, Anstrom KJ, Shah MR, Braunwald E, Cappola TP; NHLBI Heart Failure Clinical Research Network. Effects of Liraglutide on Clinical Stability Among Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):500-8. doi: 10.1001/jama.2016.10260. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All patients randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide | Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily. Liraglutide: Active Drug |
| BG001 | Placebo | Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily. Placebo: Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomized subjects. | Posted | Mean | Standard Deviation | rank | Randomization to 180 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Left Ventricular End-Diastolic Volume Index | Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days. | All randomized subjects. | Posted | Mean | Standard Deviation | ml per meter squared | Baseline to 180 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Left Ventricular End-systolic Volume Index | Change in left ventricular end-systolic volume index from baseline to day 180. | All randomized subjects. | Posted | Mean | Standard Deviation | ml per meter squared | Baseline to 180 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Left Ventricular Ejection Fraction | Change in left ventricular ejection fraction from baseline to day 180 | All randomized subjects. | Posted | Mean | Standard Deviation | percent | Baseline to 180 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Medial Filling Pressure | Change in medial filling pressure baseline to day 180. | All randomized subjects. | Posted | Mean | Standard Deviation | m/sec | Baseline to 180 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Lateral Filling Pressure | Change in lateral filling pressure baseline to day 180. | All randomized subjects. | Posted | Mean | Standard Deviation | m/sec | Baseline to 180 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in 6 Minute Walk Distance | Change in 6 minute walk distance baseline to day 30 | All randomized subjects. | Posted | Mean | Standard Deviation | meters | Baseline to day 30 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in 6 Minute Walk Distance | Change in 6 minute walk distance baseline to 90 days. | All randomized subjects. | Posted | Mean | Standard Deviation | meters | Baseline to 90 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in 6 Minute Walk Distance | Change in 6 minute walk distance baseline to 180 days. | All randomized subjects. | Posted | Mean | Standard Deviation | meters | Baseline to 180 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | All randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 30 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | All randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 90 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | All randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to day 180 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | All randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 30 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | All randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 90 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | All randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 180 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Individual Component of the Primary Endpoint- Mortality | Individual component of the primary endpoint of mortality at 180 days after randomization | All randomized subjects. | Posted | Number | participants | Randomization to 180 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Individual Component of the Primary Endpoint- Heart Failure Hospitalization | Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days | All randomized subjects. | Posted | Number | participants | Randomization to 180 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | All randomized subjects. | Posted | Mean | Standard Deviation | weighted average of ratio to baseline | Baseline to 180 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | All randomized subjects. | Posted | Mean | Standard Deviation | rank | Baseline to 180 days |
|
|
Baseline to day 210.
All serious adverse events documented from baseline to day 210. According to protocol: Non-serious adverse events will not be collected on the eCRF but should be documented in source documents and followed according to local standard of care. Non-serious adverse events were not reported to sponsor, and therefore not reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liraglutide | Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous (SQ) daily. Liraglutide: Active Drug | 33 | 154 | 0 | 0 | ||
| EG001 | Placebo | Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous (SQ) daily. Placebo: Placebo | 33 | 146 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastrointentinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hepatic Encephalopathy | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Viral Rash | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyperolmolar Hyperglycaemic State | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adrian Hernandez, MD | Duke Clinical Research Institute | 919-668-7515 | adrian.hernandez@duke.edu |
| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|