Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Factors Associated With Normal Exercise Capacity in Patients With Single Ventricle (SV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04026542
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
M3C (complex congenital heart disease) French Network
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease
Univentricular Heart

Detailed Description:

This study is cross-sectionnal, multicentric national (M3C network), descriptive, observational.

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 will be included. Patients refuse the use of medical data will be excluded.

The main objective of our study is to describe the rate of "great SV" (VO2max ≥ 80%) within the general population of SV. The secondary objectives are to compare the two groups: group "great SV" with VO2max ≥ 80% versus group SV with VO2max < 80%.

The following criteria will be collected

Anatomical : left SV, right SV, undetermined SV, total cavopulmoary shunt, partial cavopulmonary shunt

Clinic: NYHA status, saturation, medical treatment, number of surgery procedure, number of catheterization procedure, presence of pacemaker or implantable defibrillator, presence of arrythmia.

Morbidity: number oh hospitalization during the year, presence of arrhythmia, cirrhosis and hepatic carcinoma, exudative enteropathy , plastic bronchitis, venous thromboses, stroke.

Echocardiography: ejection fraction of SV, 2D Strain of SV, atrioventricular valve regurgitation, aortic stenosis, aspect of the flow in the cavopulmonary shunt.

Cardiac MRI: ejection fraction of SV

Cardiac catheterization: mean pulmonary arterial pressure, pulmonary arterial wedge pressure, presence of fistulae.

Cardiopulmonary exercise test : VO2max, anaerobic threesold, VE/VCO2 slope, oxygen uptake efficiciency slope, maximal heart rate, oxygene pulse and saturation at exercise.

Pulmonary functional test : forced expiratory volume in 1 seconde (FEV1), the forced vital capacity (FVC), the FEV1/FVC ratio (FEV1/FVC%), DLCO and residual volume.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Factors Associated With Normal Exercise Capacity in Patients With Single Ventricle: the Multicenter Cross-sectional Study
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. rate of "great SV" (VO2max ≥ 80%) within the general population of SV [ Time Frame: 1 day ]
    • measurement of the VO2max at the annual cardiopulmonary exercise test.
    • rate of patient who have a VO2max ≥ 80% in this population of SV recruited.


Secondary Outcome Measures :
  1. Comparison of the 2 groups: "great SV" versus others SV. [ Time Frame: 1 day ]
    Multivariate analysis with the following data to define parameters associated with "great SV": Anatomical, Clinic, Morbidity, Echocardiography, Cardiac MRI, Cardiac catheterization, Cardiopulmonary exercise test, Pulmonary functional test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion criteria:

- 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.

Exclusion criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026542


Contacts
Layout table for location contacts
Contact: Pascal AMEDRO, MD, PhD 0467336632 ext 33 p-amedro@chu-montpellier.fr

Locations
Layout table for location information
France
Uh Montpellier Recruiting
Montpellier, France, 34295
Contact: Arthgur GAVOTTO, MD    04 67 33 66 32 ext 33    a-gavotto@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
M3C (complex congenital heart disease) French Network
Investigators
Layout table for investigator information
Principal Investigator: Arthur GAVOTTO, MD University Hospital, Montpellier

Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04026542    
Other Study ID Numbers: RECHMPL19_0330
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
VO2max
Fontan
Congenital heart disease
Single ventricle