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FIGHT
CompletedPhase 2Results postedFunctional Impact of GLP-1 for Heart Failure Treatment (FIGHT)
Functional Impact of GLP-1 for Heart Failure Treatment
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
25
Recruiting sites
—
Enrollment
300
actual
Study population
Heart failure
Key I/E criterion
•EF ≤40%
Primary endpoint
•Heart-failure composite (All-cause death, Heart-failure hospitalization, NT-proBNP, change)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (38)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Cardiovascular outcomes
2 endpointsIndividual Component of the Primary Endpoint- Mortality
Time frame:Randomization to 180 days
All-cause death
time to event, event
SNOMED 419620001
Posted result
| Group | Value (number), participants | 95% CI |
|---|---|---|
| Liraglutide | 19 | — |
| Placebo | 16 | — |
Individual Component of the Primary Endpoint- Mortality
Time frame:Randomization to 180 days
All-cause death
time to event, event
SNOMED 419620001
Heart failure
36 endpointsGlobal Ranking of Predefined Events
Time frame:Randomization to 180 days
Heart-failure composite
composite event, event
componentsAll-cause death, Heart-failure hospitalization, NT-proBNP, change
Posted result
| Group | Value (mean), rank | 95% CI |
|---|---|---|
| Liraglutide | 145.5 | — |
| Placebo | 155.7 | — |
Global Ranking of Predefined Events
Time frame:Randomization to 180 days
Heart-failure composite
composite event, event
componentsAll-cause death, Heart-failure hospitalization, NT-proBNP, change
Change in Left Ventricular End-Diastolic Volume Index
Time frame:Baseline to 180 days
change from baseline, improvement
Posted result
| Group | Value (mean), ml per meter squared | 95% CI |
|---|---|---|
| Liraglutide | 3.37 | — |
| Placebo | -2.91 | — |
Change in Left Ventricular End-systolic Volume Index
Time frame:Baseline to 180 days
change from baseline, improvement
Posted result
| Group | Value (mean), ml per meter squared | 95% CI |
|---|---|---|
| Liraglutide | 1.16 | — |
| Placebo | -3.47 | — |
Change in Left Ventricular Ejection Fraction
Time frame:Baseline to 180 days
change from baseline, improvement
Posted result
| Group | Value (mean), percent | 95% CI |
|---|---|---|
| Liraglutide | 1.07 | — |
| Placebo | 1.37 | — |
Change in Medial Filling Pressure
Time frame:Baseline to 180 days
medial filling pressure
change from baseline, improvement
Posted result
| Group | Value (mean), m/sec | 95% CI |
|---|---|---|
| Liraglutide | 1.12 | — |
| Placebo | 0.25 | — |
Change in Lateral Filling Pressure
Time frame:Baseline to 180 days
change from baseline, improvement
Posted result
| Group | Value (mean), m/sec | 95% CI |
|---|---|---|
| Liraglutide | -0.05 | — |
| Placebo | 0.39 | — |
Change in 6 Minute Walk Distance
Time frame:Baseline to day 30
6-minute walk distance
change from baseline, improvement
Posted result
| Group | Value (mean), meters | 95% CI |
|---|---|---|
| Liraglutide | 50.4 | — |
| Placebo | 37.3 | — |
Change in 6 Minute Walk Distance
Time frame:Baseline to 90 days
6-minute walk distance
change from baseline, improvement
Posted result
| Group | Value (mean), meters | 95% CI |
|---|---|---|
| Liraglutide | 56.8 | — |
| Placebo | 38.7 | — |
Change in 6 Minute Walk Distance
Time frame:Baseline to 180 days
6-minute walk distance
change from baseline, improvement
Posted result
| Group | Value (mean), meters | 95% CI |
|---|---|---|
| Liraglutide | 55.7 | — |
| Placebo | 55.3 | — |
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame:Baseline to 30 days
KCCQ clinical summary
change from baseline, improvement
Posted result
| Group | Value (mean), units on a scale | 95% CI |
|---|---|---|
| Liraglutide | 14.69 | — |
| Placebo | 14.44 | — |
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame:Baseline to 90 days
KCCQ clinical summary
change from baseline, improvement
Posted result
| Group | Value (mean), units on a scale | 95% CI |
|---|---|---|
| Liraglutide | 13.86 | — |
| Placebo | 11.72 | — |
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame:Baseline to day 180
KCCQ clinical summary
change from baseline, improvement
Posted result
| Group | Value (mean), units on a scale | 95% CI |
|---|---|---|
| Liraglutide | 13.79 | — |
| Placebo | 13.14 | — |
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame:Baseline to 30 days
KCCQ total score
change from baseline, improvement
Posted result
| Group | Value (mean), units on a scale | 95% CI |
|---|---|---|
| Liraglutide | 12.98 | — |
| Placebo | 14.01 | — |
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame:Baseline to 90 days
KCCQ total score
change from baseline, improvement
Posted result
| Group | Value (mean), units on a scale | 95% CI |
|---|---|---|
| Liraglutide | 14.17 | — |
| Placebo | 10.62 | — |
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.
Time frame:Baseline to 180 days
KCCQ total score
change from baseline, improvement
Posted result
| Group | Value (mean), units on a scale | 95% CI |
|---|---|---|
| Liraglutide | 13.44 | — |
| Placebo | 13.25 | — |
Individual Component of the Primary Endpoint- Heart Failure Hospitalization
Time frame:Randomization to 180 days
Heart-failure hospitalization
time to event, event
SNOMED 84114007
Posted result
| Group | Value (number), participants | 95% CI |
|---|---|---|
| Liraglutide | 63 | — |
| Placebo | 50 | — |
Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP
Time frame:Baseline to 180 days
NT-proBNP, change
percent change from baseline, improvement
Posted result
| Group | Value (mean), weighted average of ratio to baseline | 95% CI |
|---|---|---|
| Liraglutide | 335.81 | — |
| Placebo | 317 | — |
Global Ranking of Predefined Events
Time frame:Baseline to 180 days
Heart-failure composite
composite event, event
componentsAll-cause death, Heart-failure hospitalization, Urgent heart-failure visit, NT-proBNP, change
Posted result
| Group | Value (mean), rank | 95% CI |
|---|---|---|
| Liraglutide | 144.29 | — |
| Placebo | 157.05 | — |
Change in Left Ventricular End-Diastolic Volume Index
Time frame:Baseline to 180 days
change from baseline, improvement
Change in Left Ventricular End-systolic Volume Index
Time frame:Baseline to 180 days
change from baseline, improvement
Change in Left Ventricular Ejection Fraction
Time frame:Baseline to 180 days
change from baseline, improvement
Change in Medial Filling Pressure
Time frame:Baseline to 180 days
change from baseline, improvement
Change in Lateral Filling Pressure
Time frame:Baseline to 180 days
change from baseline, improvement
Change in 6 Minute Walk Distance
Time frame:Baseline to day 30
6-minute walk distance
change from baseline, improvement
Change in 6 Minute Walk Distance
Time frame:Baseline to 90 days
6-minute walk distance
change from baseline, improvement
Change in 6 Minute Walk Distance
Time frame:Baseline to 180 days
6-minute walk distance
change from baseline, improvement
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame:Baseline to 30 days
KCCQ clinical summary
change from baseline, improvement
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame:Baseline to 90 days
KCCQ clinical summary
change from baseline, improvement
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame:Baseline to day 180
KCCQ clinical summary
change from baseline, improvement
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame:Baseline to 30 days
KCCQ total score
change from baseline, improvement
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame:Baseline to 90 days
KCCQ total score
change from baseline, improvement
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.
Time frame:Baseline to 180 days
KCCQ total score
change from baseline, improvement
Individual Component of the Primary Endpoint- Heart Failure Hospitalization
Time frame:Randomization to 180 days
Heart-failure hospitalization
time to event, event
SNOMED 84114007
Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP
Time frame:Baseline to 180 days
NT-proBNP, change
percent change from baseline, improvement
Global Ranking of Predefined Events
Time frame:Baseline to 180 days
composite event, event
componentsAll-cause death, Heart-failure hospitalization, Urgent heart-failure visit, NT-proBNP, change
Publications (4)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Scientific reports2022 Jun 2PMID35654972doi:10.1038/s41598-022-12973-0via clinicaltrials gov reference derived + pubmed nct search
- Circulation. Heart failure2020 May (month)PMID32362166doi:10.1161/CIRCHEARTFAILURE.119.006758via clinicaltrials gov reference derived + pubmed nct search
- ESC heart failure2018 Dec (month)PMID30120812doi:10.1002/ehf2.12334via clinicaltrials gov reference derived + pubmed nct search
- JAMA2016 Aug 2PMID27483064doi:10.1001/jama.2016.10260via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.