Clinical trial NCT04467242: Right Ventricular Diastolic Dysfunction
Official title: Interaction Between Right Heart Dysfunction and Emphysema: Impact of Endoscopic Lung Volume Reduction (RVDD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Emphysema
Right Heart Dysfunction
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients with severe emphysema and right heart dysfunction

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.


Eligibility criteria: 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

Primary outcomes:
measure: Estimate the change in right diastolic cardiac function after reduction of emphysema
timeFrame: 1 day
Secondary outcomes:
measure: Estimate the change in right systolic heart function
timeFrame: 1 day
measure: Estimate the change in right cardiac contractility
timeFrame: 1 day
measure: Estimate ventriculo-arterial coupling
timeFrame: 1 day
measure: Evaluate the evolution of symptoms assessed
timeFrame: 1 day
measure: Assessing exercice performance
timeFrame: 1 day
measure: Evaluate the evolution of respiratory function
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Arnaud Bourdin, MD PhD
role: STUDY_DIRECTOR
References: