Dapagliflozin Heart Failure Readmission

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin

Criteria

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