Status:
RECRUITING
Effect of Dual Bronchodilation With Umeclidinium/Vilanterol on Patients With COPD, Hyperinflation and Heart Failure
Lead Sponsor:
Luis Puente Maestu
Conditions:
Copd
Heart Failure
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief 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 systo...
Detailed Description
Phase IV clinical trial, single-center, double-blind, randomized, two-period crossover, placebo-controlled, to determine the effect of treatment with umeclidinium/vilanterol 55/22 μg compared with pla...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04522596
Start Date
May 21 2021
End Date
December 1 2024
Last Update
February 28 2024
Active Locations (1)
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1
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007