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

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

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)

Conditions3

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