Short-term Effects of Dapagliflozin on Peak VO2 in HFrEF — DAPA-VO2  

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title: Short-term Effects of Dapagliflozin on Peak VO2 in Patients With Heart Failure With Reduced Ejection Fraction

Status Completed

Clinical Trial Summary

This study will be a double-blind multicenter randomized study (1:1) to evaluate the effect of dapagliflozin 10 mg per day or placebo on short-term functional capacity evaluated through changes in peak oxygen consumption.

Clinical Trial Description

This study will be a double-blind multicenter randomized study (1:1) to evaluate the effect of dapagliflozin 10 mg per day or placebo on short-term functional capacity evaluated through changes in peak oxygen consumption. This trial will include patients with stable symptomatic heart failure with reduced ejection fraction (HFrEF). Efficacy endpoints will be evaluated at 3 time points: 1) baseline (before dapagliflozin/placebo administration), 2) 30 days after randomization, and, 3) 90 days after randomization. An intermediate clinical visit will be performed one week after study initiation.

Pre-and post-treatment evaluations (at baseline, 30 and 90 days) will include clinical assessment, cardiopulmonary exercise stress test, echocardiography, 6-minute walk test (6MWT), and quality of life indicators (Minnesota Living with Heart Failure Questionnaire -MLHFQ).

The investigators postulate that dapagliflozin 10 mg/day improves short-term functional capacity of patients with symptomatic HFrEF through multifactorial mechanisms, such as diuretic effect and improvement in myocardial energetic efficiency. ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

• NCT number: NCT04197635
• Study type: Interventional
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2019
• Completion date: April 19, 2022