Short-term Effects of Dapagliflozin on Peak VO2 in HFrEF
Condition: Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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.
    

Intervention name(s): Maximal functional capacity by cardiopulmonary exercise testing; Echocardiography; Evaluation of health related quality of life; Submáximal functional capacity assesment by 6 minutes walk test; Clinical evaluation
Intervention type(s): Diagnostic Test; Diagnostic Test; Behavioral; Diagnostic Test; Other
Intervention description(s): It will be done with cycle ergometer (CORTEX Metamax3B), starting with 10W of power and increasing 10W every minute. During the test, heart rate, rhythm and blood pressure will be monitored. Gas exchange data shall be evaluated every 10 seconds and the peak oxygen consumption (peak VO2) shall be considered the maximum value obtained during the last 20 seconds of exercise. The main parameters to be determined are: maximum functional capacity, peak VO2, slope of the VE/VCO2 ratio, and chronotropic incompetence variables. It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation.; The following parameters will be evaluated: a)left ventricular volumes; b) left ventricular systolic function; and c)left atrial volume and E/e' ratio. It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation.; Assessment of the quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ), Spanish version. It will be completed at baseline and at 30 and 90 days after treatment initiation. The score of the questionnaire is 0 to 105 points.; It will be performed in an area equipped for cardiopulmonary resuscitation. Subjects will be asked not to perform a vigorous physical exercise in the previous 2 hours. They will be allowed to have a light meal before the test. Before the test, the vital signs will be determined in a seated position after a rest of 10 minutes. Subjects will be instructed to walk at their own pace to cover as much distance as possible in 6 minutes. It will be performed by a trained nurse blind to study treatment at baseline and at 30 and 90 days after treatment initiation.; Evaluation of signs and symptoms of heart failure
Other intervention name(s): peak oxygen consumption; Diastolic and Systolic function; Quality of life; 6 minutes walk test
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model 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 The patients will be randomized to receive dapagliflozin or placebo. Once the inclusion criteria are fulfilled and the informed consent signed, patients will be randomized, and 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure with Reduced Ejection Fraction; Functional Capacity; Quality of life