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Right Ventricular Diastolic Dysfunction (RVDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04467242
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease
COPD Emphysema Right Heart Dysfunction

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Interaction Between Right Heart Dysfunction and Emphysema: Impact of Endoscopic Lung Volume Reduction (RVDD)
Estimated Study Start Date : July 20, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Estimate the change in right systolic heart function [ Time Frame: 1 day ]
    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

  2. Estimate the change in right cardiac contractility [ Time Frame: 1 day ]
    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.

  3. Estimate ventriculo-arterial coupling [ Time Frame: 1 day ]
    Estimate ventriculo-arterial coupling before and after reduction of emphysema assessed by the Ees/Ea ratio, obtained by KT Loop procedure

  4. Evaluate the evolution of symptoms assessed [ Time Frame: 1 day ]
    Evaluate the evolution of symptoms assessed by the Mmrc questionnaire and the CATCOPD questionnaire before and after reduction of emphysema.

  5. Assessing exercice performance [ Time Frame: 1 day ]
    Assessing exercice performance by the 6 minutes walk test before and after reduction of emphysema.

  6. Evaluate the evolution of respiratory function [ Time Frame: 1 day ]
    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients with severe emphysema and right heart dysfunction
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467242


Contacts
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Contact: Arnaud Bourdin, MD PhD 467336091 ext 33 a-bourdin@chu-montpellier.fr

Locations
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France
Uh Montpellier
Montpellier, France, 34295
Contact: Arnaud BOURDIN, MD PhD    46733609 ext 33    a-bourdin@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Arnaud Bourdin, MD PhD University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04467242    
Other Study ID Numbers: RECHMPL20_0372
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Emphysema
Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases