Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT)

Short name FIGHT

NCTNCT01800968 (opens ClinicalTrials.gov in a new tab)Other idPro00042633Other id5U10HL084904-09
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
300 participants (actual)
Sponsor
Duke University · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Apr 2013
Primary completion
Oct 2015
Completion
Oct 2015
First posted
28 Feb 2013 (estimated)
Last update posted
15 Feb 2017
Conditions
Acute Heart Failure

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 2

    FIGHT

    NCT01800968

    Apr 2013 to Oct 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Liraglutide

    Increasing dose from 0.6mg, 1.2mg to 1.8mg SQ daily.

  • Placebo comparator

    Placebo

    Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg SQ daily.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Global Ranking of Predefined Events

    Time frame · Randomization to 180 days

    Registry description

    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 outcomes(18)

  1. Change in Left Ventricular End-Diastolic Volume Index

    Time frame · Baseline to 180 days

    Registry description

    Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days.

  2. Change in Left Ventricular End-systolic Volume Index

    Time frame · Baseline to 180 days

    Registry description

    Change in left ventricular end-systolic volume index from baseline to day 180.

  3. Change in Left Ventricular Ejection Fraction

    Time frame · Baseline to 180 days

    Registry description

    Change in left ventricular ejection fraction from baseline to day 180

  4. Change in Medial Filling Pressure

    Time frame · Baseline to 180 days

    Registry description

    Change in medial filling pressure baseline to day 180.

  5. Change in Lateral Filling Pressure

    Time frame · Baseline to 180 days

    Registry description

    Change in lateral filling pressure baseline to day 180.

  6. Change in 6 Minute Walk Distance

    Time frame · Baseline to day 30

    Registry description

    Change in 6 minute walk distance baseline to day 30

  7. Change in 6 Minute Walk Distance

    Time frame · Baseline to 90 days

    Registry description

    Change in 6 minute walk distance baseline to 90 days.

  8. Change in 6 Minute Walk Distance

    Time frame · Baseline to 180 days

    Registry description

    Change in 6 minute walk distance baseline to 180 days.

  9. Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame · Baseline to 30 days

    Registry description

    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.

  10. Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame · Baseline to 90 days

    Registry description

    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.

  11. Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame · Baseline to day 180

    Registry description

    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.

  12. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

    Time frame · Baseline to 30 days

    Registry description

    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.

  13. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

    Time frame · Baseline to 90 days

    Registry description

    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.

  14. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.

    Time frame · Baseline to 180 days

    Registry description

    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.

  15. Individual Component of the Primary Endpoint- Mortality

    Time frame · Randomization to 180 days

    Registry description

    Individual component of the primary endpoint of mortality at 180 days after randomization

  16. Individual Component of the Primary Endpoint- Heart Failure Hospitalization

    Time frame · Randomization to 180 days

    Registry description

    Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days

  17. Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP

    Time frame · Baseline to 180 days

    Registry description

    Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days

  18. Global Ranking of Predefined Events

    Time frame · Baseline to 180 days

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Randomization to 180 days

Global Ranking of Predefined Events

GroupValue (rank)Spread
Liraglutide145.588.1
Placebo155.785.3
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline to 180 days

Change in Left Ventricular End-Diastolic Volume Index

GroupValue (ml per meter squared)Spread
Liraglutide3.3731.9
Placebo-2.9132.04
Secondary outcomeMean· Baseline to 180 days

Change in Left Ventricular End-systolic Volume Index

GroupValue (ml per meter squared)Spread
Liraglutide1.1626.2
Placebo-3.4726.5
Secondary outcomeMean· Baseline to 180 days

Change in Left Ventricular Ejection Fraction

GroupValue (percent)Spread
Liraglutide1.079.1
Placebo1.3710.0
Secondary outcomeMean· Baseline to 180 days

Change in Medial Filling Pressure

GroupValue (m/sec)Spread
Liraglutide1.1218.8
Placebo0.2517.8
Secondary outcomeMean· Baseline to 180 days

Change in Lateral Filling Pressure

GroupValue (m/sec)Spread
Liraglutide-0.0512.3
Placebo0.3913.1
Secondary outcomeMean· Baseline to day 30

Change in 6 Minute Walk Distance

GroupValue (meters)Spread
Liraglutide50.4110.8
Placebo37.399.6
Secondary outcomeMean· Baseline to 90 days

Change in 6 Minute Walk Distance

GroupValue (meters)Spread
Liraglutide56.8132.7
Placebo38.7115.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LiraglutideIncreasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous (SQ) daily. Liraglutide: Active Drug–33 / 1540 / 0
PlaceboPlacebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous (SQ) daily. Placebo: Placebo–33 / 1460 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2022

1 result

Plasma metabolites associated with functional and clinical outcomes in heart failure with reduced ejection fraction with and without type 2 diabetes.

Lerman et al. 2022Scientific reportscited by 7

PMID 35654972PMC9163122DOI 10.1038/s41598-022-12973-0PUB-35654972

CC BY1 result
Download PDFSee results (1)

Indexing hint: Randomized controlled trial · 2020

2 results

Effects of Liraglutide on Worsening Renal Function Among Patients With Heart Failure With Reduced Ejection Fraction: Insights From the FIGHT Trial.

Redouane et al. 2020Circulation. Heart failurecited by 13

PMID 32362166PMC7906045DOI 10.1161/circheartfailure.119.006758PUB-32362166

Rights unknown2 results
Source linkSee results (2)

Indexing hint: Randomized controlled trial · 2018

2 results

Liraglutide and weight loss among patients with advanced heart failure and a reduced ejection fraction: insights from the FIGHT trial.

Sharma et al. 2018ESC heart failurecited by 39

PMID 30120812PMC6300815DOI 10.1002/ehf2.12334PUB-30120812

Free to read · publisher termsCC BY-NC2 results
Read at sourceSee results (2)

Indexing hint: Randomized controlled trial · 2016

7 results

Effects of Liraglutide on Clinical Stability Among Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial.

Margulies et al. 2016JAMAcited by 576

PMID 27483064PMC5021525DOI 10.1001/jama.2016.10260PUB-27483064

Rights unknown7 results
Source linkSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.