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

NCT03379831 | Completed

• 1 other identifier: 9825
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease

Keywords

systemic right ventricle; quality of life; VO2; oxygen uptake; exercise test; congenital heart disease

Outcome Measures

Primary Outcomes (1)

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

  First day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient over 18 years of age, with a right ventricle in the systemic position

You may qualify if:

• 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)

You may not qualify if:

• Objection of the patient
• Impossibility of performing an exercise test
• Inability to understand and / or complete the questionnaire

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

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

Montpellier, 34295, France

Location

Related Publications (2)

• 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.

  PMID: 31256996 BACKGROUND

• 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-related quality of life in patients with a systemic right ventricle: the QUALISYSTEMIC study. Eur J Cardiovasc Nurs. 2025 Dec 29;24(8):1260-1271. doi: 10.1093/eurjcn/zvaf156.

  PMID: 40794615 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 20, 2017
• Study Start: January 12, 2018
• Primary Completion: July 4, 2019
• Study Completion: July 4, 2019
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

FR (1)