NCT04522596CompletedPhase 4
Effect of Dual Bronchodilation With Umeclidinium/Vilanterol on Patients With COPD, Hyperinflation and Heart Failure
Phase IV, Single-center, Double Blind, Randomized, Crossover, Placebo-controlled Study, to Investigate the Effect of Dual Bronchodilation With Umeclidinium Vilanterol on Patients With COPD, Hyperinflation and Heart Failure.
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 17 Aug 2020
- Start date
- 21 May 2021
- Primary completion date
- 29 May 2026
- Lead sponsor
- Luis Puente Maestu
- Diseases
- Heart failure, COPD
- NCT number
- NCT04522596
- EU CT number
- 2024-519513-61-00
- EudraCT number
- 2019-004427-20
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 60
- From 21 May 2021 to the primary completion date, 29 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Do not sign the informed consent
Who the study is looking for
- 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)
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.