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Effects of sildenafil on the pulmonary microvascular disease of symptomatic smoker

Effects of sildenafil on exercise responses in symptomatic individuals with evidence of tobacco-associated pulmonary microvascular disease: randomized, double-blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9t6rd7
Enrollment
Unknown
Registered
2020-01-22
Start date
2020-02-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco use

Interventions

Group 1 consisted of active smokers or former smokers for more than 10 years without spirometric diagnosis of chronic obstructive pulmonary disease
number of individuals in this group will be 16
The subjects will be submitted to an incremental test to the exercise tolerance limit by cardiopulmonary test in cycle ergometer. In this test, after 2 minutes of rest and 2 minutes of warm-up with mi
They will also be submitted to an incremental test to the tolerance limit by cardiopulmonary exercise test in cycle ergometer. Constant load tests will be performed on separate days, within one week,
Drug
D02.065.884.675

Sponsors

Universidade Federal de Mato Grosso do Sul
Lead Sponsor
Hospital Universitário de Mato Grosso do Sul
Collaborator

Eligibility

Age
35 Years to 80 Years

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

MeasureTime 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

MeasureTime 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

Public ContactLeandro Goelzer

Hospital Universitário de Mato Grosso do Sul

lgoelzer@terra.com.br5506733453149

Outcome results

None listed

Source: REBEC (via WHO ICTRP)