Factors Associated With Normal Exercise Capacity in Patients With Single Ventricle

NCT04026542 | Completed

• 1 other identifier: RECHMPL19_0330
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The congenital heart disease (CHD) is the firts cause of congenital birth defects. Medical and surgical advances completely changed the epidemiology of CHD. Among these CHD, the univentricular heart, or single ventricle (SV), is a disease whose medical-surgical progress has completely changed the epidemiology. The SV at birth receives systemic and pulmonary venous returns in the single functional cavity and provides systemic and pulmonary flow. The SV undergoes a severe volumetric overload and considerably increases its work, which is not viable for the long time. In 1968, Professor Francis Fontan created the palliative surgery of the univentricular heart. It consists in establishing a derivation of the systemic venous blood from the two vena cava veins directly to the pulmonary arteries, without a sub-pulmonary ventricle. So, the VU no longer undergoes volumetric overload, and eliminates cyanosis. In this "Fontan circulation", there is no pump to push the blood in the pulmonary arteries, only the remaining systemic post-capillary energy (reflection of the central venous pressure) allows to drive the blood through the lungs with a risk of stasis upstream (right overload) and a limited pre-charge downstream, which can lead to severe consequences: limited exercise capacity, systolic and diastolic dysfunction of the SV, arrhythmia, cyanosis, cirrhosis and hepatic carcinoma, exudative enteropathy , plastic bronchitis, venous thromboses, deaths. There is a great heterogeneity within this family of SV with extremely varied evolutionary profiles. The cardiorespiratory exercise test, which has become a "gold standard", makes it possible to assess the severity of CHD. In our study on the aerobic fitness of children with CHD, the investigators found that 44% of children with SV had normal aerobic fitness (\> 80% of the theoretical VO2max)1. Some good prognostic criteria are already described: left SV, good VU function, total cavopulmonary shunt in young age, etc. But the investigators know that these elements are not enough to explain why some SV, which the investigators will call the "great-SV", have a better aerobic fitness. The main objective of our study is to describe the population of "great SV" (VO2max ≥ 80%) within the general population of SV. The investigators thus wish to determine the prognostic criteria favorable to a good aerobic fitness in univenticular heart disease.

Conditions

Univentricular Heart

Keywords

VO2max; Fontan; Congenital heart disease; Single ventricle

Outcome Measures

Primary Outcomes (1)

• rate of "great SV" (VO2max ≥ 80%) within the general population of SV

  * measurement of the VO2max at the annual cardiopulmonary exercise test. * rate of patient who have a VO2max ≥ 80% in this population of SV recruited.

  1 day

Secondary Outcomes (1)

• Comparison of the 2 groups: "great SV" versus others SV.

  1 day

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a single ventricle according to the international classification ACC-CHD who had a cardiopulmonary exercise test in the year during usual follow-up.

You may qualify if:

• \- Children ≥ 6 years old and adults with a single ventricle according to the international classification ACC-CHD and who had a cardiopulmonary exercise test in the year during usual follow-up.

You may not qualify if:

• \- Patients refuse the use of medical data will be excluded.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• M3C (complex congenital heart disease) French Network: collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Univentricular Heart; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

• Arthur GAVOTTO, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

• Pascal AMEDRO, MD, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2020
• Last Updated: May 19, 2021

Record last verified: 2020-03

Locations

FR (1)