Dapagliflozin on Hypotensive Heart Failure Patients After Sacubitril/Valsartan Therapy

• Status: Completed
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care. However, hypotensive patients who generally have higher risks comparing to normotensive patients, were under represented in the DAPA-HF. The investigators aimed to evaluate clinical effects of dapagliflozin on hypotensive heart failure patients receiving chronic sacubitril/valsartan treatment.

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

Details

• Lead Sponsor: Cheng-Hsin General Hospital
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Adrenergic beta-Antagonists; Carvedilol; Dapagliflozin; LCZ 696; Mineralocorticoid Receptor Antagonists; Mineralocorticoids; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

Inclusion Criteria:

• chronic symptomatic HF with New York Heart Association (NYHA) class II-IV and left ventricular ejection fraction (LVEF) less than 40%

• treatment with stable and maximal tolerable dose of Sac/Val, beta-blocker with or without mineralocorticoid receptor antagonist

• 6-minute walking-distance (6MWD)≥ 100meters and ≤425 meters at enrollment

• systolic blood pressure ≤100 mmHg at enrollment

Exclusion Criteria:

• hemodialysis

• severe co-morbidities with life expectancy less than 1 year

• type 1 diabetes mellitus

• ever treated with any type of sodium glucose cotransporter 2 inhibitor (SGLT2i)