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Completed NCT04522596

Effect of Dual Bronchodilation With Umeclidinium/Vilanterol on Patients With COPD, Hyperinflation and Heart Failure

Conditions: Copd, Heart Failure

Sex: All
Ages: 40 Years – 85 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 60
Sponsor: Luis Puente Maestu

Location: Hospital General Universitario Gregorio Marañón Madrid

Summary

Double-blind, randomized, two-period crossover, placebo-controlled, single-center study, to determine the effect of umeclidinium/vilanterol 55/22 μg compared with placebo on the increase in left systolic chamber function during exercise in patients with COPD, lung hyperinflation and mild to moderate left ventricular dysfunction.

Eligibility Criteria

Inclusion Criteria: * Age between 40 and 85 years with a clinical diagnosis of COPD * Airflow limitation indicated by a screening post-bronchodilator FEV1 \< 80% and \>35% predicted and a post-bronchodilator FEV1/FVC \< 0.7 * Smoking history of at least ten pack-years * Baseline lung hyperinflation with a residual volume of more than 135% predicted * Stable heart failure * Left ventricle ejection fraction in the range of 35% to 55%. * A suitable ultrasonic window from the apical view * No exacerbation within 2 months before study recruitment (defined as the use of systemic corticoids, antibiotics, or hospitalization) Exclusion Criteria: * Do not sign the informed consent * Unstable cardiovascular diseases * Atrial fibrillation or other arrhythmias requiring treatment * Unstable ischemic heart disease * Uncontrolled hypertension * Patients unable to undergo cardiac MR scanning (claustrophobia or carrying non-MR-compatible devices) * Patients unable to perform an exercise test (locomotor conditions)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04522596). StuddyBuddy aggregates publicly available trial information.