Effect of a dual bronchodilator on COPD patients with 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.
This study is testing if a new inhaler can help people with both COPD and heart failure breathe better during exercise.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Hospital General Universitario Gregorio Marañon Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT04522596 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of umeclidinium/vilanterol on patients suffering from chronic obstructive pulmonary disease (COPD) and heart failure. It is a Phase IV, double-blind, randomized, two-period crossover, placebo-controlled study conducted at the Gregorio Marañon University Hospital in Madrid. Participants will receive either the active treatment or a placebo for 14 days, followed by a washout period and then the alternate treatment. The primary goal is to assess improvements in left systolic chamber function during exercise in this patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 85 with COPD, lung hyperinflation, and stable heart failure.
Not a fit: Patients with unstable cardiovascular diseases or significant arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance heart function and overall exercise capacity in patients with COPD and heart failure.
How similar studies have performed: Other studies have shown promising results with dual bronchodilation in COPD, but this specific combination in heart failure patients is less explored.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Madrid
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Luis Puente-Maestú, Prof
- Email: luis.puente@salud.madrid.org
- Phone: 914703910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.