Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2020-07-20
2022-06-01
Brief Summary
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Emphysema by increasing intrathoracic pressure appears to affect cardiac function.
Interestingly, previous studies have shown a link between the telediastolic volume of the right ventricle (measured by RMI) and the intensity of emphysema.
Our hypothesis is that the emphysema by increasing intrathoracic pressure leads to or accentuates right cardiac diastolic dysfunction by decreasing compliance and cardiac preload.
To verify this hypothesis the investigators will perform KT loop procedures in order to acquire intracardiac pressure/volume curves before and after lung volume reduction.
The pressure/volume curves allow the analysis of systolic and diastolic function, cardiac contractility and loading conditions.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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COPD patients
COPD patients with severe emphysema and right heart dysfunction
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Arnaud Bourdin, MD PhD
Role: STUDY_DIRECTOR
University Hospital, Montpellier
Locations
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Uh Montpellier
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Arnaud BOURDIN, MD PhD
Role: primary
Other Identifiers
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RECHMPL20_0372
Identifier Type: -
Identifier Source: org_study_id