Heart Failure Clinical Trial
Dapagliflozin at Discharge on Hospital Heart Failure Readmission
Summary
This study will be the first trial to evaluate the safety and efficacy of dapagliflozin treatment in preventing readmissions/ER visits/urgent clinic visits, and death in patients with and without T2D after admission for heart failure. Treatment with SGLT2-i has been shown to reduce both heart failure hospitalizations and mortality in patients with established heart disease. However, the time of initiation of SGLT2-i therapy has not been evaluated in patients with HF. In addition, the impact of treatment on HF symptoms quality of life, resource utilization, and cost-effectiveness of dapagliflozin versus placebo will be evaluated. The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of patients with heart failure.
Full Description
The prevalence of both heart failure and type 2 diabetes (T2D) or prediabetes are reaching epidemic proportions globally and in the United States. More than 40% of patients with established heart failure (HF) have diabetes.
This study will be the first trial to evaluate the safety and efficacy of dapagliflozin treatment in preventing hospital re-admissions/ER visits/urgent clinic visits, and death in patients with and without T2D after admission for heart failure. Treatment with SGLT2-i has been shown to reduce both heart failure hospitalizations and mortality in patients with established heart disease. However, the time of initiation of SGLT2-i therapy has not been evaluated in patients with HF. In addition, the impact of treatment on HF symptoms quality of life, resource utilization, and cost-effectiveness of dapagliflozin versus placebo will be evaluated. The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of patients with heart failure.
Patients with and without diabetes who have acute decompensated heart failure (ADHF) will be randomized to receive either dapagliflozin (10 mg once daily) or placebo at hospital discharge for 26 weeks.
Eligibility Criteria
Inclusion Criteria:
Males or females between the ages of 18 and 90 years, with ADHF, and New York Heart Association (NYHA) class II, III, or IV symptoms discharged after hospital admission with a clinical diagnosis ADHF
Elevated natriuretic peptide tests measure levels of BNP (NT-pro-BNP) ≥300 pg/ml or B-type natriuretic peptide (BNP) ≥100 pg/ml on admission
Interpretable echocardiogram during hospital admission (or within 12 months prior to index hospitalization)
Blood glucose level <400 mg/dL without evidence of diabetic ketoacidosis (serum bicarbonate <18 milliequivalent (mEq)/L or positive serum or urinary ketones), in patients with T2D
Exclusion Criteria:
Age < 18 or > 90 years
Subjects with a history of type 1 diabetes
Treatment with thiazolidinediones (TZDs) or SGLT2-i during the past 3 months of admission
Recurrent episodes of severe hypoglycemia or hypoglycemic unawareness
History of recurrent HF admissions considered to be due to non-compliance (evaluated by the research staff for participation)
Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3 times upper limit of normal
Patients with impaired renal function (GFR < 25 ml/min)
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Patients on ventricular assist devices (VADs)
History of heart transplant or listed for heart transplant
History of cardiac surgery (within 90 days prior to enrollment) or planned cardiac interventions within the following 6 months, including percutaneous coronary intervention (PCI), ablation, cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillator (ICD)
HF due to restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valvular diseases, hypertrophic cardiomyopathy, or congenital heart disease
History of SGLT2-i allergy
Systolic blood pressure < 100 mmHg
Uncontrolled hypertension, defined as a systolic blood pressure > 200 mmHg at randomization
Female subjects who are pregnant or breast-feeding at time of enrollment into the study
Females of childbearing potential who are not using adequate contraceptive methods
In hospice or expected life expectancy less than 6 months
Patients with diabetic foot infection, osteomyelitis and history of amputation of lower extremities within 6 months of admission
Patients anticipated to undergo major surgical procedures during the following 6 months
Patients with active hematuria, urinary tract infection (UTI), or history of frequent UTIs or genital mycotic infections
Uncontrolled atrial fibrillation or atrial flutter with a resting heart rate >110bpm documented by ECG at randomization
Any condition that in the opinion of the investigator would contraindicate the assessment of distance walked in 6 minutes (6MWD)
Chronic pulmonary disease, i.e. with known forced expiratory volume in the first second (FEV1) <50% requiring home oxygen, or oral steroid therapy or current hospitalization for severe chronic obstructive pulmonary disease (COPD) thought to be a primary contributor to dyspnea, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension
Patients with active history of bladder cancer
Patients with previous history of diabetic ketoacidosis, per American Diabetes Association (ADA) criteria
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There are 3 Locations for this study
Atlanta Georgia, 30322, United States
New Orleans Louisiana, 70118, United States
Philadelphia Pennsylvania, 19122, United States
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