Right Ventricular Diastolic Dysfunction

COPD Clinical Trial

— RVDD  

Official title:

Interaction Between Right Heart Dysfunction and Emphysema: Impact of Endoscopic Lung Volume Reduction (RVDD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04467242
• Other study ID #: RECHMPL20_0372
• Status: Recruiting
• Start date: July 20, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: Arnaud Bourdin, MD PhD
• Phone: 467336091
• Email: a-bourdin[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Emphysema
• Pulmonary Emphysema
• Right Heart Dysfunction

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the change in right diastolic cardiac function after reduction of emphysema	Estimate the change in right diastolic cardiac function after reduction of emphysema : assessed by the change in the slope end diastolic pressure volume relationship (EDPVR mmHg/ml) obtained by KT Loop procedure	1 day
Secondary	Estimate the change in right systolic heart function	Estimate the change in right systolic heart function before and after reduction of emphysema assessed by the cardiac output (L/min), the stroke volume (ml), the end systolic pressure (mmHg), the end systolic volume (mmHg), obtained by KT Loop procedure	1 day
Secondary	Estimate the change in right cardiac contractility	Estimate the change in right cardiac contractility before and after reduction of emphysema assessed by the slope end systolic pressure volume relationship (mmHg/ml), obtained by KT Loop procedure.	1 day
Secondary	Estimate ventriculo-arterial coupling	Estimate ventriculo-arterial coupling before and after reduction of emphysema assessed by the Ees/Ea ratio, obtained by KT Loop procedure	1 day
Secondary	Evaluate the evolution of symptoms assessed	Evaluate the evolution of symptoms assessed by the Mmrc questionnaire and the CATCOPD questionnaire before and after reduction of emphysema.	1 day
Secondary	Assessing exercice performance	Assessing exercice performance by the 6 minutes walk test before and after reduction of emphysema.	1 day
Secondary	Evaluate the evolution of respiratory function	Evaluate the evolution of respiratory function before and after reduction of emphysema assessed by the FEV1 (Liters and % of predicted value), the FVC (Liters and % of predicted value), the RV (Liters and % of predicted value), the TLC (Liters and % of predicted value) obtained by spirometry/plethysmography.	1 day