Right Ventricular Diastolic Dysfunction (RVDD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Emphysema; COPD; Right Heart Dysfunction

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Arnaud Bourdin, MD PhD; Phone Number: 33 467336091; Email: a-bourdin@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • UH Montpellier
    • Contact: Arnaud BOURDIN, MD PhD; Phone Number: 33 46733609; Email: a-bourdin@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD patients with severe emphysema and right heart dysfunction

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
COPD patients; COPD patients with severe emphysema and right heart dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Assessing exercice performance	Assessing exercice performance by the 6 minutes walk test before and after reduction of emphysema.	1 day
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (ACTUAL): July 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 27, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: RECHMPL20_0372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No