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

NCT01800968 | Completed Phase 2 Results DMC

• 2 other identifiers: Pro000426335U10HL084904-09
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (18)

• Change in Left Ventricular End-Diastolic Volume Index

  Baseline to 180 days

• Change in Left Ventricular End-systolic Volume Index

  Baseline to 180 days

• Change in Left Ventricular Ejection Fraction

  Baseline to 180 days

• Change in Medial Filling Pressure

  Baseline to 180 days

• Change in Lateral Filling Pressure

  Baseline to 180 days

Study Arms (2)

Liraglutide

ACTIVE COMPARATOR

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

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Liraglutide DRUG

Active Drug

Also known as: Victoza

Liraglutide

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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)
• AHFS is the primary cause of hospitalization
• Prior clinical diagnosis of HF
• 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)
• On evidence-based medication for HF (including beta-blocker and ACE-inhibitor/ARB) or previously deemed intolerant
• 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")
• Willingness to provide informed consent

You may not qualify if:

• AHFS due to acute myocarditis or acute Myocardial Infarction
• Ongoing hemodynamically significant arrhythmias contributing to HF decompensation
• Inotrope, intra-aortic balloon pump (IABP) or other mechanical circulatory support use at the time of consent. Prior use will not exclude a patient.
• Current or planned left ventricular assist device therapy in next 180 days
• United Network for Organ Sharing status 1A or 1B
• Hemoglobin (Hgb) \< 8.0 g/dl
• Glomerular filtration rate(GFR) \< 20 ml/min/1.73 m2 within 48 hours of consent
• Systolic blood pressure \< 80 mmHg at consent
• Resting Heart Rate \> 110 at consent
• 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)
• Percutaneous Coronary Intervention, coronary artery bypass grafting or new biventricular pacing within past 4 weeks
• Primary hypertrophic cardiomyopathy
• Infiltrative cardiomyopathy
• Constrictive pericarditis or tamponade
• Complex congenital heart disease

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (25)

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston VA Healtcare System

West Roxbury, Massachusetts, 02132, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Saint Louis University Hospital

St Louis, Missouri, 63117, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Southeast Regional Medical Center

Lumberton, North Carolina, 28538, United States

Location

University Hospitals- Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Metro Health System

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Lancaster Heart and Stroke Foundation

Lancaster, Pennsylvania, 17603, United States

Location

University of Pennsylvaina

Philadelphia, Pennsylvania, 19104, United States

Location

Jefferson Medical College

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Michael Debakey VA Medical Center

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States

Location

Utah VA Medical Center

Salt Lake City, Utah, 84132, United States

Location

The University of Vermont- Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Related Publications (4)

• 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.

  PMID: 35654972 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.

  PMID: 32362166 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.

  PMID: 30120812 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.

  PMID: 27483064 DERIVED

MeSH Terms

Interventions

Liraglutide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Adrian Hernandez, MD
• Organization: Duke Clinical Research Institute

adrian.hernandez@duke.edu

919-668-7515

Study Officials

• Adrian Hernandez, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Eugene Bruanwald, MD

  Harvard University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 28, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 15, 2017
• Results First Posted: February 15, 2017

Record last verified: 2017-02

Locations

US (25)