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

Launched by LUIS PUENTE MAESTU · Aug 19, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how a combination medication called umeclidinium/vilanterol affects patients who have both chronic obstructive pulmonary disease (COPD) and heart failure. The goal is to see if this medication can help improve the heart's ability to pump blood during exercise, especially in patients who experience lung hyperinflation (which means their lungs are overly full of air). This study is being conducted at a single center and involves participants who will receive either the medication or a placebo (a "dummy" treatment) in a random order, without knowing which one they are taking at any given time.

To participate in this trial, individuals need to be between 40 and 85 years old and have a confirmed diagnosis of COPD, along with mild to moderate heart failure. They should also have a history of smoking and certain lung measurements that indicate they have lung hyperinflation. Participants can expect to undergo tests that assess their heart and lung function, including exercise tests and cardiac imaging. It’s important to note that those with certain heart conditions or who cannot complete the required tests will not be eligible. The trial is currently recruiting participants, and it could offer insights into better treatment options for people managing both COPD and heart failure.

Gender

ALL

Eligibility 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)