Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Males or females between the ages of 18 and 80 years, with or without diabetes, ejection fraction of 45% or less, and New York Heart Association (NYHA) class II, III, or IV symptoms discharged after hospital admission with a clinical diagnosis ADHF. 2. Elevated NT-pro-BNP ≥300 pg/ml or BNP (≥100 pg/ml) on admission. 3. Interpretable echocardiogram during hospital admission (or within 12 months prior to index hospitalization) 4. Blood glucose level <400 mg/dL without evidence of diabetic ketoacidosis (serum bicarbonate <18 mEq/L or positive serum or urinary ketones)- Applies to patients with T2D.

Exclusion Criteria

  1. Age < 18 or > 80 years. 2. Subjects with a history of type 1 diabetes. 3. Treatment with TZDs or SGLT2-i during the past 3 months of admission. 4. Recurrent episodes of severe hypoglycemia or hypoglycemic unawareness. 5. History of recurrent HF admissions considered to be due to non-compliance (evaluated by the research staff for participation) 6. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of normal. 7. Patients with impaired renal function (GFR < 25 ml/min). 8. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 9. Patients on ventricular assist devices (VADs) 10. History of heart transplant or listed for heart transplant 11. History of cardiac surgery* (within 90 days prior to enrollment) or planned cardiac interventions* within the following 6 months *Includes: PCI, ablation, CRT-ICD 12. HF due to restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valvular diseases, hypertrophic cardiomyopathy, or congenital heart disease. 13. History of SGLT2-i allergy 14. Systolic blood pressure < 100 mmHg 15. Uncontrolled hypertension, defined as a systolic blood pressure > 200 mmHg at randomization 16. Female subjects who are pregnant or breast-feeding at time of enrollment into the study. 17. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice). 18. In hospice or expected life expectancy less than 6 months 19. Patients with diabetic foot infection, osteomyelitis and history of amputation of lower extremities within 6 months of admission 20. Patients anticipated to undergo major surgical procedures during the following 6 months 21. Patients with active hematuria, urinary tract infection (UTI), or history of frequent UTIs or genital mycotic infections 22. Uncontrolled atrial fibrillation or atrial flutter with a resting heart rate >110bpm documented by ECG at randomization. 23. Any condition that in the opinion of the investigator would contraindicate the assessment of 6MWD 24. Chronic pulmonary disease i.e. with known FEV1 <50% requiring home oxygen, or oral steroid therapy or current hospitalization for severe COPD thought to be a primary contributor to dyspnea, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension 25. Patients with active history of bladder cancer. 26. Patients with previous history of diabetic ketoacidosis, per ADA criteria

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dapagliflozin
Participants will receive dapagliflozin 10 mg once daily
  • Drug: Dapagliflozin
    Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Participants will receive dapagliflozin 10 mg once daily
    Other names:
    • FARXIGA
Placebo Comparator
Placebo
Participants will receive placebo once daily
  • Drug: Placebo
    Participants will receive placebo tablet once daily

Recruiting Locations

Tulane University
New Orleans, Louisiana 70118
Contact:
Blaire Williams
bwilliams7@tulane.edu

More Details

Status
Recruiting
Sponsor
Emory University

Study Contact

Guillermo Umpierrez, MD
404-778-1665
geumpie@emory.edu

Detailed 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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.