FIGHTGLP-1 para una mayor estabilidad clínica en pacientes con insuficiencia cardíaca

Fecha de inicio: 1 de abril de 2013

Inclusion 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 Exclusion Criteria: 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