COPDRVDDNCT04467242
Right Ventricular Diastolic Dysfunction
An observational study of COPD and Emphysema, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Emphysema, Right Heart Dysfunction
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2020to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients with severe emphysema and right heart dysfunction
Who may be able to join
- 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"
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- 15% ≤ FEV1post ≤ 50%
- Residual volume ≥ 175% predicted
- TLC ≥ 100% predicted
- Optimal medical management
- 150m ≤ 6MWD ≤ 500m
- mMRC ≥ 2
- Physical activity ≥ 2/Week (≥ 30minutes)
Who cannot join
- ≥2 hospitalizations/year for EACOPD
- Recent EACOPD (≤ 3months)
- ≥ 50ml mucus/day
- PAPm ≥35mmHg
- PaCO2 ≥ 55mmHg
- Bubble ≥ 1/3 hemithorax
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34295
Arnaud BOURDIN, MD PhD, 46733609 ext. 33, a-bourdin@chu-montpellier.fr
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | COPD patients with severe emphysema and right heart dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1 day
Assessing exercice performance
Assessing exercice performance by the 6 minutes walk test before and after reduction of emphysema.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start20 Jul 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Bourdin, MD PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467242
- Sponsor's protocol ID
- RECHMPL20_0372
- Acronym
- RVDD
- Status last verified
- Jun 2020
- First submitted
- 1 Jul 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Right Heart Dysfunction and Emphysema: Impact of Endoscopic Lung Volume Reduction (RVDD)
- ClinicalTrials.gov ID
- NCT04467242
- Acronym / sponsor ID
- RVDD / RECHMPL20_0372
- Conditions
- COPD, Emphysema, Right Heart Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | –COPD patients with severe emphysema and right heart dysfunction |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients with severe emphysema and right heart dysfunction
Key inclusion criteria (13 listed)
- At least 40 years
- A smoking history
- Smoking cessation ≥ 6 months
- FEV1/FVC ≤ 0,7
- Severe emphysema (destruction ≥ 50%)
Key exclusion criteria (13 listed)
- ≥2 hospitalizations/year for EACOPD
- Recent EACOPD (≤ 3months)
- ≥ 50ml mucus/day
- PAPm ≥35mmHg
- PaCO2 ≥ 55mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate the change in right diastolic cardiac function after reduction of emphysema
Time frame: 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
6 secondary outcomes
Estimate the change in right systolic heart function
Time frame: 1 day
Estimate the change in right cardiac contractility
Time frame: 1 day
Estimate ventriculo-arterial coupling
Time frame: 1 day
Evaluate the evolution of symptoms assessed
Time frame: 1 day
Assessing exercice performance
Time frame: 1 day
Evaluate the evolution of respiratory function
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Bourdin, MD PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Emphysema, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Bourdin, MD PhD (467336091 ext. 33, a-bourdin@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the change in right diastolic cardiac function after reduction of emphysema (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.