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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Heart Failure

In brief

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.

Key facts

Study ID

NCT01800968

Run by

Duke University

People needed

300

Starts

2013-04-01

Expected to finish

2015-10-01

Last updated by the study team

2017-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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)
• 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
• Non-cardiac pulmonary edema
• More than moderate aortic or mitral stenosis
• Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation
• Sepsis, active infection (excluding cystitis) or other comorbidity driving the HF decompensation
• 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
• Terminal illness (other than HF) with expected survival of less than 1 year
• Previous adverse reaction to the study drug
• Receipt of any investigational product in the previous 30 days.
• Enrollment or planned enrollment in another randomized therapeutic clinical trial in next 6 months.

Where it is running

• Christiana Care Health Services — Newark, Delaware, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston VA Healtcare System — West Roxbury, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Saint Louis University Hospital — St Louis, Missouri, United States
• Duke University — Durham, North Carolina, United States
• Southeast Regional Medical Center — Lumberton, North Carolina, United States
• University Hospitals- Case Medical Center — Cleveland, Ohio, United States
• Metro Health System — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Lancaster Heart and Stroke Foundation — Lancaster, Pennsylvania, United States
• University of Pennsylvaina — Philadelphia, Pennsylvania, United States
• Jefferson Medical College — Philadelphia, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Michael Debakey VA Medical Center — Houston, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• University of Utah School of Medicine — Salt Lake City, Utah, United States
• Utah VA Medical Center — Salt Lake City, Utah, United States
• The University of Vermont- Fletcher Allen Health Care — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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