Right Ventricular Diastolic Dysfunction (NCT04467242) | Clinical Trial Compass
UnknownNot Applicable
Right Ventricular Diastolic Dysfunction
France30 participantsStarted 2020-07-20
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Estimate the change in right diastolic cardiac function after reduction of emphysema