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OpenTrials
Completed

NCT Number: NCT03379831

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation between the short form SF-36 scores and maximum oxygen uptake (peak VO2)

    Time frame: First day

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

An Observational, Cross-sectional, Multicenter Study Evaluating the Correlation Between Quality of Life and Aerobic Physical Fitness of Patients With a Systemic Right Ventricle.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2017
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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