Right Ventricular Diastolic Dysfunction

• Conditions: Right Heart Dysfunction; COPD; Emphysema

• Registration Number: NCT04467242
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-10
• Study Start: 2020-07-20
• Last Update Submitted: 2020-11-27
• Last Update Posted: 2020-12-01
• Primary Completion: 2021-07-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate the change in right diastolic cardiac function after reduction of emphysema	1 day	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

Secondary Outcome Measures

Name	Time	Method
Estimate the change in right systolic heart function	1 day	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
Estimate the change in right cardiac contractility	1 day	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.
Estimate ventriculo-arterial coupling	1 day	Estimate ventriculo-arterial coupling before and after reduction of emphysema assessed by the Ees/Ea ratio, obtained by KT Loop procedure
Assessing exercice performance	1 day	Assessing exercice performance by the 6 minutes walk test before and after reduction of emphysema.
Evaluate the evolution of symptoms assessed	1 day	Evaluate the evolution of symptoms assessed by the Mmrc questionnaire and the CATCOPD questionnaire before and after reduction of emphysema.
Evaluate the evolution of respiratory function	1 day	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.

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France