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Right Ventricular Diastolic Dysfunction

Interaction Between Right Heart Dysfunction and Emphysema: Impact of Endoscopic Lung Volume Reduction (RVDD)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04467242
Acronym
RVDD
Enrollment
30
Registered
2020-07-10
Start date
2020-07-20
Completion date
2022-06-01
Last updated
2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Emphysema, 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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Estimate the change in right diastolic cardiac function after reduction of emphysema1 dayEstimate 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

MeasureTime frameDescription
Estimate the change in right cardiac contractility1 dayEstimate 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.
Estimate ventriculo-arterial coupling1 dayEstimate ventriculo-arterial coupling before and after reduction of emphysema assessed by the Ees/Ea ratio, obtained by KT Loop procedure
Estimate the change in right systolic heart function1 dayEstimate 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
Assessing exercice performance1 dayAssessing exercice performance by the 6 minutes walk test before and after reduction of emphysema.
Evaluate the evolution of respiratory function1 dayEvaluate 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.
Evaluate the evolution of symptoms assessed1 dayEvaluate the evolution of symptoms assessed by the Mmrc questionnaire and the CATCOPD questionnaire before and after reduction of emphysema.

Countries

France

Contacts

Primary ContactArnaud Bourdin, MD PhD
a-bourdin@chu-montpellier.fr467336091

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026