NCT03030235

Dapagliflozin in PRESERVED Ejection Fraction Heart Failure

Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients With PRESERVED Ejection Fraction Heart Failure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: Saint Luke's Health System · Academic / Other
• Sex: All
• Age: 19 Years – 119 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure, disease specific biomarkers, symptoms, health status and quality of life in patients with chronic heart failure with preserved systolic function.

Detailed description

A 12-week randomized, double-blind, placebo-controlled trial to evaluate the effects of once-daily dapagliflozin 10 mg on heart failure disease-specific biomarkers (NTproBNP and BNP), symptoms, health status, and quality of life in patients with chronic heart failure with preserved systolic function. An imaging substudy will also be conducted to explore the effects of dapagliflozin vs. placebo on various echocardiographic parameters.

Conditions

• Chronic Heart Failure With Preserved Systolic Function

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10Mg Oral Tablet	Dapagliflozin 10Mg Oral Tablet
DRUG	Dapagliflozin matching placebo	Dapagliflozin matching placebo

Timeline

• Start date: 2017-03-01
• Primary completion: 2021-08-13
• Completion: 2021-08-13
• First posted: 2017-01-24
• Last updated: 2022-10-19
• Results posted: 2022-10-19

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study