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UNKNOWNNCT04467242

Right Ventricular Diastolic Dysfunction

Heart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are very commonly associated. Emphysema by increasing intrathoracic pressure appears to affect cardiac function....

Lead sponsor: University Hospital, Montpellier•1 locations•View source on ClinicalTrials.gov

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Contacts

Arnaud Bourdin, MD PhD

CONTACT

467336091 a-bourdin@chu-montpellier.fr

Sponsors

Lead Sponsor

University Hospital, Montpellier

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•At least 40 years
•A smoking history
•Smoking cessation ≥ 6 months
•FEV1/FVC ≤ 0,7
•Severe emphysema (destruction ≥ 50%)
•Peak tricuspid regurgitation velocity \< 2,8 m/s or presence of other echocardiographic "PH signs"
•15% ≤ FEV1post ≤ 50%
•Residual volume ≥ 175% predicted
•TLC ≥ 100% predicted
•Optimal medical management
•150m ≤ 6MWD ≤ 500m
•mMRC ≥ 2
•Physical activity ≥ 2/Week (≥ 30minutes)

Exclusion Criteria

•≥2 hospitalizations/year for EACOPD
•Recent EACOPD (≤ 3months)
•≥ 50ml mucus/day
•PAPm ≥35mmHg
•PaCO2 ≥ 55mmHg
•Bubble ≥ 1/3 hemithorax
•Lung fibrosis, bronchiectasis, lung cancer, homolateral surgery
•Left ventricular ejection fraction ≤ 45%, unstable heart disease
•Life expectancy ≤ 1 year
•Contraindication to anesthesia
•Allergy to nitinol or silicone
•Corticotherapy ≥ 10mg/day
•Patient under legal protection

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 1, 2020Terms

Trial snapshot

StatusUNKNOWN

Phase—

Enrollment30

Start dateJul 2020

Last updatedDec 1, 2020

Condition

COPD Emphysema Right Heart Dysfunction

Locations shown

Uh Montpellier

Montpellier

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2020Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions