Correlation Between Quality of Life and Aerobic Physical Fitness of Patients With a Systemic Right Ventricle

NCT ID: NCT03379831

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-12

Study Completion Date

2019-07-04

Brief Summary

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Congenital heart disease (CHD) is the most common congenital malformations. The right ventricle in the sub-aortic position, or "systemic right ventricle" is one of these complex cardiac diseases. Several studies show that adults with CHD and especially systemic right ventricle have reduced exercise capacity. In addition, studies have shown that there is a correlation between alteration of aerobic physical capacity and alteration of right ventricular systolic function.

Understanding and assessing the determinants of the physical capacity of patients with systemic right ventricles and evaluating their quality of life could allows us to improve their therapeutic management and also to expand patient indications to a program cardiac rehabilitation. This can benefit them on their exercise capacity, their tolerance to exercise and their quality of life.

The aim is to study the correlation between the quality of life and the aerobic physical fitness of patients with a systemic right ventricle and to determine the clinical and paraclinical parameters that have an impact on the aerobic physical fitness of these patients. The quality of life of patients with a systemic right ventricle will be compared to that of the general population.

Detailed Description

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100 patients will be enrolled in this study. 25 sites will participate to the enrollment, belonging to the French national network for complex congenital heart diseases (M3C) .

Patient is included during his annual medical check-up. Quality of life questionnaire and other examinations are performed during this site visit. Its is a part of his usual care. No supplementary visit, directly related to the research, are necessary.

Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient over 18 years of age
* Patient with a right ventricle in the systemic position
* Patient having undergone an annual assessment in accordance with the ESC (European Society of Cardiology) 2010 recommendations: clinical examination, ECG, echocardiography, cardiopulmonary exercise test (with VO2)

Exclusion Criteria

* Objection of the patient
* Impossibility of performing an exercise test
* Inability to understand and / or complete the questionnaire
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

Montpellier, , France

Site Status

Countries

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France

References

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Gavotto A, Abassi H, Rola M, Serrand C, Picot MC, Iriart X, Thambo JB, Iserin L, Ladouceur M, Bredy C, Amedro P. Factors associated with exercise capacity in patients with a systemic right ventricle. Int J Cardiol. 2019 Oct 1;292:230-235. doi: 10.1016/j.ijcard.2019.06.030. Epub 2019 Jun 13.

Reference Type BACKGROUND
PMID: 31256996 (View on PubMed)

Padovani P, Werner O, Huguet H, Vaksmann G, Iriart X, Thambo JB, Pierard S, Pasquet A, Domanski O, Godart F, Bredy C, Lefort B, Iserin L, Ladouceur M, Karsenty C, Maragnes P, Moceri P, Cohen S, Hascoet S, Cohen L, Andrianoely M, Combes N, Abassi H, Picot MC, Cornuault L, Amedro P. Health-Reported Quality of Life in Patients with A Systemic Right Ventricle: The QUALISYSTEMIC Study. Eur J Cardiovasc Nurs. 2025 Aug 5:zvaf156. doi: 10.1093/eurjcn/zvaf156. Online ahead of print.

Reference Type DERIVED
PMID: 40794615 (View on PubMed)

Other Identifiers

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9825

Identifier Type: -

Identifier Source: org_study_id

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