Effect of Dual Bronchodilation With Umeclidinium/Vilanterol on Patients With COPD, Hyperinflation and Heart Failure (CHHEF)
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ClinicalTrials.gov Identifier: NCT04522596 |
Recruitment Status :
Recruiting
First Posted : August 21, 2020
Last Update Posted : February 28, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Copd Heart Failure | Drug: Umeclidinium/vilanterol Other: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Phase IV clinical trial, single-center, double-blind, randomized, two-period crossover, placebo-controlled. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Actual Study Start Date : | May 21, 2021 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Umeclidinium/vilanterol
Umeclidinium/vilanterol 55/22 μg inhaled once a day for 14 days.
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Drug: Umeclidinium/vilanterol
Umeclidinium/vilanterol 55/22 μg inhaled once a day |
Placebo Comparator: Placebo
Placebo inhaled once a day for 14 days.
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Other: Placebo
Placebo inhaled once a day |
- Change from baseline on the increase in exercise stroke volume. [ Time Frame: 0, 14, 42 days (Visits 4, 5 and 7 respectively) ]Baseline-corrected, time-velocity integral (a direct surrogate of SV) during peak exercise, as measured by exercise Doppler-echocardiography.
- Change from baseline on the increase in exercise oxygen pulse. [ Time Frame: 0, 14, 42 days (Visits 4, 5 and 7 respectively) ]Maximal oxygen pulse on a cardiopulmonary exercise test on Cycle-ergometer
- Change from baseline on the reduction of resting hyperinflation.. [ Time Frame: Screening (-14), 0, 14, 42 days (Visits 4, 5 and 7 respectively) ]Resting lung volumes (Inspiratory capacity, functional residual capacity and residual volume)
- Change from baseline on the reduction of dynamic hyperinflation. [ Time Frame: Screening (-14), 0, 14, 42 days (Visits 4, 5 and 7 respectively) ]Inspiratory Capacity every 2 minutes during the incremental exercise test.
- Change from baseline on resting dyastolic left heart function. [ Time Frame: 0, 14, 42 days (Visits 4, 5 and 7 respectively) ]Left and right cardiac chambers volumes at rest in patients, as measured by MRI (Baseline)
- Change from baseline on resting systolic left cardiac function. [ Time Frame: 0, 14, 42 days (Visits 4, 5 and 7 respectively) ]Baseline-corrected peak ejection intraventricular pressure difference (peak EIVPD) at peak exercise, as measured by exercise color-Doppler M-mode echocardiography.
- Change from baseline on resting right cardiac function. [ Time Frame: 0, 14, 42 days (Visits 4, 5 and 7 respectively) ]Pulmonary acceleration time in the main pulmonary artery as measured by phase-contrast MRI.
- Change from baseline on resting left cardiac function. [ Time Frame: 0, 14, 42 days (Visits 4, 5 and 7 respectively) ]Baseline-corrected peak intraventricular diastolic pressure gradient (peak DIVPD) at peak exercise - diastolic suction, as measured by exercise color-Doppler M-mode echocardiography.
- Change from baseline on PROMs (Impact of disease). [ Time Frame: 0, 14, 42 days (Visits 4, 5 and 7 respectively) ]Average changes in COPD Assessment Test (CAT)
- Change from baseline on PROMs (dyspnea). [ Time Frame: 0, 14, 42 days (Visits 4, 5 and 7 respectively) ]Proportion of patients with Clinically relevant changes in Transition dyspnea index ( -4 and -2 respectively)
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Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522596
Contact: Luis Puente-Maestú, Prof | 914703910 | luis.puente@salud.madrid.org | |
Contact: Walther I Giron, MD | +34658566028 | walter_giron2@hotmail.com |
Spain | |
Hospital General Universitario Gregorio Marañón | Recruiting |
Madrid, Spain, 28007 | |
Contact: Walther I Giron-Matute, M.D. +34658566028 walter_giron2@hotmail.com | |
Contact: Zichen Ji, MD +34617882547 jizich72@gmail.com | |
Principal Investigator: Luis Puente-Maestu, M.D | |
Sub-Investigator: Ángela Gomez-Sacristan, Nurse |
Study Director: | Luis Puente-Maestu, Prof | Instituto de Investigación Sanitaria Gregorio Mrañón |
Responsible Party: | Luis Puente Maestu, Professor, Hospital General Universitario Gregorio Marañon |
ClinicalTrials.gov Identifier: | NCT04522596 |
Other Study ID Numbers: |
CHHEF 2019-004427-20 ( EudraCT Number ) |
First Posted: | August 21, 2020 Key Record Dates |
Last Update Posted: | February 28, 2024 |
Last Verified: | February 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
COPD Heart failure Hyperinflation |
Heart Failure Heart Diseases Cardiovascular Diseases |