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. - CHHEF

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004427-20-ES

Enrollment

Registered

2019-12-02

Start date

2020-02-07

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary diseases with Heart Failure with eyection ventricular ejection fraction between 35-50% MedDRA version: 20.0 Level: LLT Classification code 10013108 Term: Disease obstructive lung System Organ Class: 100000004855

Interventions

Trade Name: Umeclidinium/vilanterol 55/22 mcg Product Name: Umeclidinium/vilanterol Pharmaceutical Form: Inhalation powder INN or Proposed INN: UMECLIDINIUM BROMIDE CAS Number: 869113-09-7| Current Sp

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients aged at least 40 years with a clinical diagnosis of COPD - Airflow limitation indicated by a screening post-bronchodilator FEV1 of less than 80% predicted and a post-bronchodilator FEV1 to forced vital capacity (FVC) ratio of less than 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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 exercise test (locomotor condtions)

Design outcomes

Primary

Measure	Time frame
Main Objective: To address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on the increase in exercise stroke volume (from baseline).;Secondary Objective: 1. To address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on the Reduction of dynamic hyperinflation (from baseline). 2. To address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on resting cardiac function (from baseline). 3. To address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on PROMs (from baseline) on;Primary end point(s): 1. Baseline-corrected, time-velocity integral (a direct surrogate of SV) during peak exercise, as measured by exercise Doppler-echocardiography (last satisfactory measurement). 2. Maximal oxygen pulse on a cardiopulmonary exercise test on Cycle-ergometer;Timepoint(s) of evaluation of this end point: After 14 days of washout patients will start either IMP or placebo. Two weeks afterworks all the endpoints there will be the firts evaluation. After another 14 days of washout the patients will be crossed over and expose to IMP or placebo for 14 days, point that wich a second evaluation	—

Measure

Time frame

Main Objective: To address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on the increase in exercise stroke volume (from baseline).;Secondary Objective: 1. To address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on the Reduction of dynamic hyperinflation (from baseline). 2. To address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on resting cardiac function (from baseline). 3. To address the effect (compared with placebo) of umeclidinium+vilanterol 55/22 mcg on PROMs (from baseline) on;Primary end point(s): 1. Baseline-corrected, time-velocity integral (a direct surrogate of SV) during peak exercise, as measured by exercise Doppler-echocardiography (last satisfactory measurement). 2. Maximal oxygen pulse on a cardiopulmonary exercise test on Cycle-ergometer;Timepoint(s) of evaluation of this end point: After 14 days of washout patients will start either IMP or placebo. Two weeks afterworks all the endpoints there will be the firts evaluation. After another 14 days of washout the patients will be crossed over and expose to IMP or placebo for 14 days, point that wich a second evaluation

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: After 14 days of washout patients will start either IMP or placebo. Two weeks afterworks all the endpoints there will be the firts evaluation. After another 14 days of washout the patients will be crossed over and expose to IMP or placebo for 14 days, point that wich a second evaluation;Secondary end point(s): 1. Resting lung volumes ( Inspiratory capacity, functional residual capacity and residual volume) 2. Inspiratory Capacity every 2 minutes during the incremental exercise test. 3. Left and right cardiac chambers volumes at rest in patients, as measured by MRI 4. Baseline-corrected peak ejection intraventricular pressure difference (peak EIVPD) at peak exercise, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement). 5. Pulmonary acceleration time in the main pulmonary artery as measured by phase-contrast MRI. 6. Baseline-corrected peak intraventricular diastolic pressure gradient (peak DIVPD) at peak exercise – diastolic suction, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement). 7. ProBNP levels 8. Average changes in COPD Assessment Test (CAT) and Transition dyspnea index 9. Proportion of patients with Clinically relevant changes in COPD Assessment Test (CAT) and Transition dyspnea index ( -4 and -2 respectively)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: After 14 days of washout patients will start either IMP or placebo. Two weeks afterworks all the endpoints there will be the firts evaluation. After another 14 days of washout the patients will be crossed over and expose to IMP or placebo for 14 days, point that wich a second evaluation;Secondary end point(s): 1. Resting lung volumes ( Inspiratory capacity, functional residual capacity and residual volume) 2. Inspiratory Capacity every 2 minutes during the incremental exercise test. 3. Left and right cardiac chambers volumes at rest in patients, as measured by MRI 4. Baseline-corrected peak ejection intraventricular pressure difference (peak EIVPD) at peak exercise, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement). 5. Pulmonary acceleration time in the main pulmonary artery as measured by phase-contrast MRI. 6. Baseline-corrected peak intraventricular diastolic pressure gradient (peak DIVPD) at peak exercise – diastolic suction, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement). 7. ProBNP levels 8. Average changes in COPD Assessment Test (CAT) and Transition dyspnea index 9. Proportion of patients with Clinically relevant changes in COPD Assessment Test (CAT) and Transition dyspnea index ( -4 and -2 respectively)

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Countries

Spain

Contacts

Public ContactLuis Puente

Luis Puente Maestu

luis.puente@salud.madrid.org+34914703910

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026