Phase 2 · Liraglutide

FIGHT trial results

Functional Impact of GLP-1 for Heart Failure Treatment

Global Ranking of Predefined Events (rank), Randomization to 180 days. Liraglutide: 145.5; Placebo: 155.7.

Participants
300
Status
completed
Completed
2015-10
Sponsor
Duke University

As posted on ClinicalTrials.gov (NCT01800968), updated at source Feb 15, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What FIGHT measured first

Global Ranking of Predefined Eventsrank · Randomization to 180 days · mean
Liraglutiden=154Placebon=146
145.5(88.1)155.7(85.3)
Secondary outcomes

What else it measured

Change in Left Ventricular End-Diastolic Volume Indexml per meter squared · Baseline to 180 days · mean
Liraglutiden=154Placebon=146
3.37(31.9)-2.91(32.04)
Change in Left Ventricular End-systolic Volume Indexml per meter squared · Baseline to 180 days · mean
Liraglutiden=154Placebon=146
1.16(26.2)-3.47(26.5)
Change in Left Ventricular Ejection Fractionpercent · Baseline to 180 days · mean
Liraglutiden=154Placebon=146
1.07(9.1)1.37(10.0)
Change in Medial Filling Pressurem/sec · Baseline to 180 days · mean
Liraglutiden=154Placebon=146
1.12(18.8)0.25(17.8)
Change in Lateral Filling Pressurem/sec · Baseline to 180 days · mean
Liraglutiden=154Placebon=146
-0.05(12.3)0.39(13.1)
Change in 6 Minute Walk Distancemeters · Baseline to day 30 · mean
Liraglutiden=154Placebon=146
50.4(110.8)37.3(99.6)
Change in 6 Minute Walk Distancemeters · Baseline to 90 days · mean
Liraglutiden=154Placebon=146
56.8(132.7)38.7(115.4)
Change in 6 Minute Walk Distancemeters · Baseline to 180 days · mean
Liraglutiden=154Placebon=146
55.7(133.9)55.3(127.2)
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)units on a scale · Baseline to 30 days · mean
Liraglutiden=154Placebon=146
14.69(25.90)14.44(22.03)
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)units on a scale · Baseline to 90 days · mean
Liraglutiden=154Placebon=146
13.86(24.99)11.72(23.82)
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)units on a scale · Baseline to day 180 · mean
Liraglutiden=154Placebon=146
13.79(23.83)13.14(23.60)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scoreunits on a scale · Baseline to 30 days · mean
Liraglutiden=154Placebon=146
12.98(23.82)14.01(20.09)
The trial

How FIGHT was run

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.

  • Liraglutide: Increasing dose from 0.6mg, 1.2mg to 1.8mg SQ daily.
  • Placebo: Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg SQ daily.
Who could join the trial

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...

Published papers

Papers from FIGHT

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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