Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT)
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-009924
NCT ID: NCT01800968
Sponsor Protocol Number: U1111-1132-8368
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- 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
- 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
- If diabetic, inadequate glycemic control with glucose level > 300 mg/dL within 24 hours of randomization
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.