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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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519513-61-00
Acronym
CHHEF
Enrollment
60
Registered
2024-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-20

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%

Brief summary

Baseline-corrected, time-velocity integral (a direct surrogate of SV) during peak exercise, as measured by exercise Doppler-echocardiography (last satisfactory measurement), Maximal oxygen pulse on a cardiopulmonary exercise test on cycle-ergometer

Detailed description

Resting lung volumes ( Inspiratory capacity, functional residual capacity and residual volume), Inspiratory Capacity every 2 minutes during the incremental exercise test, Left and right cardiac chambers volumes at rest in patients, as measured by MRI, Baseline-corrected peak ejection intraventricular pressure difference (peak EIVPD) at peak exercise, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement), Pulmonary acceleration time in the main pulmonary artery as measured by phase-contrast MRI, 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), ProBNP levels, Average changes in COPD Assessment Test (CAT) and Transition dyspnea index, Proportion of patients with Clinically relevant changes in COPD Assessment Test (CAT) and Transition dyspnea index ( -4 and -2 respectively)

Interventions

Sponsors

Hospital General Universitario Gregorio Maranon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Baseline-corrected, time-velocity integral (a direct surrogate of SV) during peak exercise, as measured by exercise Doppler-echocardiography (last satisfactory measurement), Maximal oxygen pulse on a cardiopulmonary exercise test on cycle-ergometer

Secondary

MeasureTime frame
Resting lung volumes ( Inspiratory capacity, functional residual capacity and residual volume), Inspiratory Capacity every 2 minutes during the incremental exercise test, Left and right cardiac chambers volumes at rest in patients, as measured by MRI, Baseline-corrected peak ejection intraventricular pressure difference (peak EIVPD) at peak exercise, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement), Pulmonary acceleration time in the main pulmonary artery as measured by phase-contrast MRI, 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), ProBNP levels, Average changes in COPD Assessment Test (CAT) and Transition dyspnea index, Proportion of patients with Clinically relevant changes in COPD Assessment Test (CAT) and Transition dyspnea index ( -4 and -2 respectively)

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026