Right Ventricular Diastolic Dysfunction (RVDD)

University Hospital Center (CHU)

Status: Unknown

Conditions: Right Heart Dysfunction; Emphysema; COPD

Study type: Observational

Funder types: Other

Identifiers

NCT04467242

RECHMPL20_0372

Details and patient eligibility

About

Heart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are very commonly associated.

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

COPD patients

Description:

COPD patients with severe emphysema and right heart dysfunction