Tobacco use
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Symptomatic vascular phenotype; Individuals of both sexes; Age between 35 and 80 years; History of smoking for more than 10 years; Sinus rhythm; Preserved left ventricular ejection fraction (higher than 50%); The evaluated patients should be able to perform spirometry, carbon monoxide diffusion test and cardiopulmonary exercise test.
Exclusion criteria
Exclusion criteria: Carrier of diabetes mellitus, bronchial asthma, previous myocardial infarction, heart failure, complex ventricular arrhythmias; Chronic atrial fibrillation; Body mass index lower than 18.5 or higher than 35 kg per m²; Anemia with hemoglobin lower than 11 g% in women and lower than 12 g% in men; Chronic hypoxemia of undetermined cause; neuromuscular, orthopedic or psychological limitation; Contraindication to the use of sildenafil citrate or previous use of it thereof.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of sildenafil use on the cycle ergometer maximum exercise tolerance time. Considering a 2-by-2 cross-sectional design and a clinically important minimum difference of 100 seconds suggested for constant load tests at 75% of the maximum power in the incremental intervention test, it was calculated that 16 Group 1 individuals with the disease and 8 healthy individuals from Group 2 give the study 85% power with a 5% alpha. The level of statistical significance will be set at p less than 0.05. | — |
Secondary
| Measure | Time frame |
|---|---|
| Define a vascular phenotype in the smoker by clinical, functional criteria and imaging resources together. ;To evaluate the effects of sildenafil on the adjustment kinetics of oxygen consumption in the transition from rest to exercise in smokers with suspected microvascular disease. | — |
Countries
Brazil
Contacts
Hospital Universitário de Mato Grosso do Sul