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FIGHT

CompletedPhase 2Results posted

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

Functional Impact of GLP-1 for Heart Failure Treatment

Lead sponsor

Duke University

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

NCT IDNCT01800968
Org study IDPro00042633
Secondary ID5U10HL084904-09

Timeline

Milestones

Study first posted2013-02-28estimated
Last update posted2017-02-15actual
Results first posted2017-02-15actual
Study start2013-04 (month precision)
Primary completion2015-10actual (month precision)
Study completion2015-10actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Heart failure

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Heart failure
36
Cardiovascular outcomes
2

Cardiovascular outcomes

2 endpoints
Secondary/registry result

Individual Component of the Primary Endpoint- Mortality

Time frame:Randomization to 180 days

All-cause death

time to event, event

SNOMED 419620001

Posted result

GroupValue (number), participants95% CI
Liraglutide19
Placebo16
p0.7764Log Rank
Secondary/protocol endpoint

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 endpoints
Primary/registry result

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

Posted result

GroupValue (mean), rank95% CI
Liraglutide145.5
Placebo155.7
p0.3087Rank score
Primary/protocol endpoint

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

Secondary/registry result

Change in Left Ventricular End-Diastolic Volume Index

Time frame:Baseline to 180 days

change from baseline, improvement

Posted result

GroupValue (mean), ml per meter squared95% CI
Liraglutide3.37
Placebo-2.91
p0.1549Regression, Linear
Secondary/registry result

Change in Left Ventricular End-systolic Volume Index

Time frame:Baseline to 180 days

change from baseline, improvement

Posted result

GroupValue (mean), ml per meter squared95% CI
Liraglutide1.16
Placebo-3.47
p0.1932Regression, Linear
Secondary/registry result

Change in Left Ventricular Ejection Fraction

Time frame:Baseline to 180 days

change from baseline, improvement

Posted result

GroupValue (mean), percent95% CI
Liraglutide1.07
Placebo1.37
p0.9535Regression, Linear
Secondary/registry result

Change in Medial Filling Pressure

Time frame:Baseline to 180 days

medial filling pressure

change from baseline, improvement

Posted result

GroupValue (mean), m/sec95% CI
Liraglutide1.12
Placebo0.25
p0.8548Regression, Linear
Secondary/registry result/low confidence

Change in Lateral Filling Pressure

Time frame:Baseline to 180 days

change from baseline, improvement

Posted result

GroupValue (mean), m/sec95% CI
Liraglutide-0.05
Placebo0.39
p0.4266Regression, Linear
Secondary/registry result

Change in 6 Minute Walk Distance

Time frame:Baseline to day 30

6-minute walk distance

change from baseline, improvement

Posted result

GroupValue (mean), meters95% CI
Liraglutide50.4
Placebo37.3
p0.1705Regression, Linear
Secondary/registry result

Change in 6 Minute Walk Distance

Time frame:Baseline to 90 days

6-minute walk distance

change from baseline, improvement

Posted result

GroupValue (mean), meters95% CI
Liraglutide56.8
Placebo38.7
p0.1309Regression, Linear
Secondary/registry result

Change in 6 Minute Walk Distance

Time frame:Baseline to 180 days

6-minute walk distance

change from baseline, improvement

Posted result

GroupValue (mean), meters95% CI
Liraglutide55.7
Placebo55.3
p0.7920Regression, Linear
Secondary/registry result

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

GroupValue (mean), units on a scale95% CI
Liraglutide14.69
Placebo14.44
p0.7026Regression, Linear
Secondary/registry result

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

GroupValue (mean), units on a scale95% CI
Liraglutide13.86
Placebo11.72
p0.2662Regression, Linear
Secondary/registry result

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

GroupValue (mean), units on a scale95% CI
Liraglutide13.79
Placebo13.14
p0.6395Regression, Linear
Secondary/registry result

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

GroupValue (mean), units on a scale95% CI
Liraglutide12.98
Placebo14.01
p0.8218Regression, Linear
Secondary/registry result

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

GroupValue (mean), units on a scale95% CI
Liraglutide14.17
Placebo10.62
p0.1124Regression, Linear
Secondary/registry result

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

GroupValue (mean), units on a scale95% CI
Liraglutide13.44
Placebo13.25
p0.8088Regression, Linear
Secondary/registry result

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

GroupValue (number), participants95% CI
Liraglutide63
Placebo50
p0.1701Log Rank
Secondary/registry result

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

GroupValue (mean), weighted average of ratio to baseline95% CI
Liraglutide335.81
Placebo317
p0.6532Regression, Linear
Secondary/registry result

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

GroupValue (mean), rank95% CI
Liraglutide144.29
Placebo157.05
p0.2033Rank score
Secondary/protocol endpoint

Change in Left Ventricular End-Diastolic Volume Index

Time frame:Baseline to 180 days

change from baseline, improvement

Secondary/protocol endpoint

Change in Left Ventricular End-systolic Volume Index

Time frame:Baseline to 180 days

change from baseline, improvement

Secondary/protocol endpoint

Change in Left Ventricular Ejection Fraction

Time frame:Baseline to 180 days

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Medial Filling Pressure

Time frame:Baseline to 180 days

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Lateral Filling Pressure

Time frame:Baseline to 180 days

change from baseline, improvement

Secondary/protocol endpoint

Change in 6 Minute Walk Distance

Time frame:Baseline to day 30

6-minute walk distance

change from baseline, improvement

Secondary/protocol endpoint

Change in 6 Minute Walk Distance

Time frame:Baseline to 90 days

6-minute walk distance

change from baseline, improvement

Secondary/protocol endpoint

Change in 6 Minute Walk Distance

Time frame:Baseline to 180 days

6-minute walk distance

change from baseline, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Time frame:Baseline to 30 days

KCCQ total score

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to 90 days

KCCQ total score

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to 180 days

KCCQ total score

change from baseline, improvement

Secondary/protocol endpoint

Individual Component of the Primary Endpoint- Heart Failure Hospitalization

Time frame:Randomization to 180 days

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Secondary/protocol endpoint

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

Secondary/protocol endpoint/low confidence

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.