Status:
COMPLETED
Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT)
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Acute Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 assoc...
Detailed Description
Hospitalization for AHFS identifies individuals at increased risk of death and re-hospitalization following discharge. This increased risk justifies intervention with novel therapy during the vulnerab...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Inability to comply with planned study procedures
- Pregnancy or breastfeeding mothers
- Women of reproductive age not on adequate contraception
- History of acute or chronic pancreatitis
- History of symptomatic gastroparesis
- Familial or personal history of medullary thyroid cancer or multiple endocrine neoplasia type-2 (MEN2)
- Prior weight-loss surgery (i.e., Roux-en-Y gastric bypass) or other gastric surgery associated with increased endogenous GLP-1 production
- Prior or ongoing treatment with GLP-1 receptor agonists
- Ongoing treatment with dipeptidyl peptide-IV inhibitors (1 week washout required)
- Ongoing treatment with thiazolidinedione
- Oxygen-dependent chronic obstructive pulmonary disease
- Diabetic patients with history of 2 or more severe hypoglycemia, Diabetic Ketoacidosis(DKA) or hyperglycemic, hyperosmotic nonketotic coma in the preceding 12 months.
- Diagnosis of Type 1 Diabetes Mellitus
- 40\. If diabetic, inadequate glycemic control with glucose level \> 300 mg/dL within 24 hours of randomization
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01800968
Start Date
April 1 2013
End Date
October 1 2015
Last Update
February 15 2017
Active Locations (25)
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1
Christiana Care Health Services
Newark, Delaware, United States, 19718
2
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287