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

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Luis Puente Maestu

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)