Right Ventricular Diastolic Dysfunction

NCT04467242 | Unknown

• 1 other identifier: RECHMPL20_0372
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Emphysema; Right Heart Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Estimate the change in right systolic heart function

  1 day

• Estimate the change in right cardiac contractility

  1 day

• Estimate ventriculo-arterial coupling

  1 day

• Evaluate the evolution of symptoms assessed

  1 day

• Assessing exercice performance

  1 day

Study Arms (1)

COPD patients

COPD patients with severe emphysema and right heart dysfunction

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients with severe emphysema and right heart dysfunction

You may qualify if:

• 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"
• % ≤ FEV1post ≤ 50%
• Residual volume ≥ 175% predicted
• TLC ≥ 100% predicted
• Optimal medical management
• m ≤ 6MWD ≤ 500m
• mMRC ≥ 2
• Physical activity ≥ 2/Week (≥ 30minutes)

You may not qualify if:

• ≥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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud Bourdin, MD PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Arnaud Bourdin, MD PhD

CONTACT

467336091; a-bourdin@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 10, 2020
• Study Start: July 20, 2020
• Primary Completion: July 1, 2021
• Study Completion: June 1, 2022
• Last Updated: December 1, 2020

Record last verified: 2020-06

Locations

FR (1)