Short-term Effects of Dapagliflozin on Peak VO2 in HFrEF

  • STATUS
    Recruiting
  • participants needed
    74
  • sponsor
    Fundación para la Investigación del Hospital Clínico de Valencia
Updated on 9 May 2021
dapagliflozin

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.

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 type 2 diabetes and 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 type 2 diabetes and symptomatic HFrEF through multifactorial mechanisms, such as diuretic effect and improvement in myocardial energetic efficiency.

Details
Condition NIDDM, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Heart Failure With Reduced Ejection Fraction, Diabetes (Pediatric), Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Echocardiography, clinical evaluation, Maximal functional capacity by cardiopulmonary exercise testing, Evaluation of quality of life health related, Submáximal functional capacity assesment by 6 minutes walk test
Clinical Study IdentifierNCT04197635
SponsorFundación para la Investigación del Hospital Clínico de Valencia
Last Modified on9 May 2021

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