Congenital Heart DiseaseNCT03379831
Correlation Between Quality of Life and Aerobic Physical Fitness of Patients With a Systemic Right Ventricle
An observational study of Congenital Heart Disease, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2018to 4 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient over 18 years of age, with a right ventricle in the systemic position
Who may be able to join
- 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)
Who cannot join
- Objection of the patient
- Impossibility of performing an exercise test
- Inability to understand and / or complete the questionnaire
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Montpellier, 34295
About this study
Official 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.
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.
Read the detailed description
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
- Congenital Heart Disease
- Keywords
- systemic right ventricle, quality of life, VO2, oxygen uptake, exercise test, congenital heart disease
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the short form SF-36 scores and maximum oxygen uptake (peak VO2)
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start12 Jan 2018
- Primary completion4 Jul 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379831
- Sponsor's protocol ID
- 9825
- Status last verified
- Oct 2023
- First submitted
- 22 Nov 2017
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31256996Padovani 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.
PubMed 40794615
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT03379831
- Acronym / sponsor ID
- 9825
- Conditions
- Congenital Heart Disease
- Keywords
- systemic right ventricle, quality of life, VO2, oxygen uptake, exercise test, congenital heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient over 18 years of age, with a right ventricle in the systemic position
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Objection of the patient
- Impossibility of performing an exercise test
- Inability to understand and / or complete the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between the short form SF-36 scores and maximum oxygen uptake (peak VO2)
Time frame: First day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 31256996Gavotto 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.
- Derived from this study: PubMed 40794615Padovani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the short form SF-36 scores and maximum oxygen uptake (peak VO2) (time frame: First day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03379831, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.