Congenital Heart DiseaseNCT03050112
Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.
A study testing MacNew questionnaire in people with Congenital Heart Disease, run by Pierre Wauthy at 1 site in Belgium.
Trial summary
Adults with a congenital heart disease, having undergone a surgical intervention or a re-do surgery in adulthood, are a growing group of subjects in the general population. This increase is explained by improved medical and surgical techniques, with a better survival rate as outcome. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- MacNew questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Feb 2017to 1 Jun 2017
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients having had surgery in adulthood for a congenital heart disease, at the Brugmann University Hospital. The group consists in patients aged 16 years or older, having had surgery between 01/01/1998 and 31/12/2015
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Adults with a congenital heart disease, having undergone a surgical intervention or a re-do surgery in adulthood, are a growing group of subjects in the general population. This increase is explained by improved medical and surgical techniques, with a better survival rate as outcome.
There is nowadays a growing interest in the quality of life of this group of subjects. However, studies give contradictory results. This can be explained on one hand by the vast majority of pathologies within this population, and on the other hand by the absence of a cardio-specific tool for quality of life measurement.
Read more
The MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life based on the exploration of three domains: physical, emotional and social.
The aim of this study is:
- to evaluate the quality of life of these patients, by using the MacNew questionnaire
- to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up
- to assess the mortality within this group of patients.
- Conditions
- Congenital Heart Disease
- Being tested
- MacNew questionnaire
- Keywords
- MacNew questionnaire, Quality of life
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacNew questionnaireOther
Patients will be asked to fill in the MacNew questionnaire on quality of life (phone contact).
| Study group | Role | What they receive |
|---|---|---|
| Congenital cardiopathy | Experimental | Patients having had surgery in adulthood for a congenital heart disease, at the Brugmann University Hospital. The group consists in patients aged 16 years or older, having had surgery between 01/01/1998 and 31/12/2015. Receives: Other: MacNew questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
MacNew questionnaire
Quality of life assessment
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start14 Feb 2017
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Wauthy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierre Wauthy, Brugmann University Hospital
- Investigators
- Halit Ozel, Principal investigator, CHU BrugmannPierre Wauthy, MD, Study director, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050112
- Sponsor's protocol ID
- CHUB-QOL cardiopathy
- Status last verified
- Nov 2017
- First submitted
- 8 Feb 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wauthy P, Massaut J, Sanoussi A, Demanet H, Morissens M, Damry N, Dessy H, Malekzadeh-Milani SG, Deuvaert FE. Ten-year experience with surgical treatment of adults with congenital cardiac disease. Cardiol Young. 2011 Feb;21(1):39-45. doi: 10.1017/S1047951110001332. Epub 2010 Oct 6.
PubMed 20923595Lane DA, Lip GY, Millane TA. Quality of life in adults with congenital heart disease. Heart. 2002 Jul;88(1):71-5. doi: 10.1136/heart.88.1.71.
PubMed 12067950Immer FF, Althaus SM, Berdat PA, Saner H, Carrel TP. Quality of life and specific problems after cardiac surgery in adolescents and adults with congenital heart diseases. Eur J Cardiovasc Prev Rehabil. 2005 Apr;12(2):138-43. doi: 10.1097/01.hjr.0000159318.62466.dc.
PubMed 15785299Fteropoulli T, Stygall J, Cullen S, Deanfield J, Newman SP. Quality of life of adult congenital heart disease patients: a systematic review of the literature. Cardiol Young. 2013 Aug;23(4):473-85. doi: 10.1017/S1047951112002351. Epub 2013 Feb 6.
PubMed 23388149Apers S, Luyckx K, Moons P. Quality of life in adult congenital heart disease: what do we already know and what do we still need to know? Curr Cardiol Rep. 2013 Oct;15(10):407. doi: 10.1007/s11886-013-0407-x.
PubMed 23955787Hofer S, Lim L, Guyatt G, Oldridge N. The MacNew Heart Disease health-related quality of life instrument: a summary. Health Qual Life Outcomes. 2004 Jan 8;2:3. doi: 10.1186/1477-7525-2-3.
PubMed 14713315Pavy B, Iliou MC, Hofer S, Verges-Patois B, Corone S, Aeberhard P, Curnier D, Henry J, Ponchon-Weess A, Oldridge N. Validation of the French version of the MacNew heart disease health-related quality of life questionnaire. Arch Cardiovasc Dis. 2015 Feb;108(2):107-17. doi: 10.1016/j.acvd.2014.09.006. Epub 2014 Nov 12.
PubMed 25453715Dixon T, Lim LL, Oldridge NB. The MacNew heart disease health-related quality of life instrument: reference data for users. Qual Life Res. 2002 Mar;11(2):173-83. doi: 10.1023/a:1015005109731.
PubMed 12018740
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.
- ClinicalTrials.gov ID
- NCT03050112
- Acronym / sponsor ID
- CHUB-QOL cardiopathy
- Conditions
- Congenital Heart Disease
- Keywords
- MacNew questionnaire, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Pierre WauthyUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 10 Feb 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.
Adults with a congenital heart disease, having undergone a surgical intervention or a re-do surgery in adulthood, are a growing group of subjects in the general population. This increase is explained by improved medical and surgical techniques, with a better survival rate as outcome.
There is nowadays a growing interest in the quality of life of this group of subjects. However, studies give contradictory results. This can be explained on one hand by the vast majority of pathologies within this population, and on the other hand by the absence of a cardio-specific tool for quality of life measurement.
The MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life based on the exploration of three domains: physical, emotional and social.
The aim of this study is:
- to evaluate the quality of life of these patients, by using the MacNew questionnaire
- to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up
- to assess the mortality within this group of patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congenital cardiopathy | Experimental | Other: MacNew questionnairePatients having had surgery in adulthood for a congenital heart disease, at the Brugmann University Hospital. The group consists in patients aged 16 years or older, having had surgery between 01/01/1998 and 31/12/2015. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having had surgery in adulthood for a congenital heart disease, at the Brugmann University Hospital. The group consists in patients aged 16 years or older, having had surgery between 01/01/1998 and 31/12/2015
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MacNew questionnairePatients will be asked to fill in the MacNew questionnaire on quality of life (phone contact). | Other | Congenital cardiopathy |
Primary outcome
MacNew questionnaire
Time frame: 30 minutes
Quality of life assessment
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 22 Nov 2017.
- Background: PubMed 20923595Wauthy P, Massaut J, Sanoussi A, Demanet H, Morissens M, Damry N, Dessy H, Malekzadeh-Milani SG, Deuvaert FE. Ten-year experience with surgical treatment of adults with congenital cardiac disease. Cardiol Young. 2011 Feb;21(1):39-45. doi: 10.1017/S1047951110001332. Epub 2010 Oct 6.
- Background: PubMed 12067950Lane DA, Lip GY, Millane TA. Quality of life in adults with congenital heart disease. Heart. 2002 Jul;88(1):71-5. doi: 10.1136/heart.88.1.71.
- Background: PubMed 15785299Immer FF, Althaus SM, Berdat PA, Saner H, Carrel TP. Quality of life and specific problems after cardiac surgery in adolescents and adults with congenital heart diseases. Eur J Cardiovasc Prev Rehabil. 2005 Apr;12(2):138-43. doi: 10.1097/01.hjr.0000159318.62466.dc.
- Background: PubMed 23388149Fteropoulli T, Stygall J, Cullen S, Deanfield J, Newman SP. Quality of life of adult congenital heart disease patients: a systematic review of the literature. Cardiol Young. 2013 Aug;23(4):473-85. doi: 10.1017/S1047951112002351. Epub 2013 Feb 6.
- Background: PubMed 23955787Apers S, Luyckx K, Moons P. Quality of life in adult congenital heart disease: what do we already know and what do we still need to know? Curr Cardiol Rep. 2013 Oct;15(10):407. doi: 10.1007/s11886-013-0407-x.
- Background: PubMed 14713315Hofer S, Lim L, Guyatt G, Oldridge N. The MacNew Heart Disease health-related quality of life instrument: a summary. Health Qual Life Outcomes. 2004 Jan 8;2:3. doi: 10.1186/1477-7525-2-3.
- Background: PubMed 25453715Pavy B, Iliou MC, Hofer S, Verges-Patois B, Corone S, Aeberhard P, Curnier D, Henry J, Ponchon-Weess A, Oldridge N. Validation of the French version of the MacNew heart disease health-related quality of life questionnaire. Arch Cardiovasc Dis. 2015 Feb;108(2):107-17. doi: 10.1016/j.acvd.2014.09.006. Epub 2014 Nov 12.
- Background: PubMed 12018740Dixon T, Lim LL, Oldridge NB. The MacNew heart disease health-related quality of life instrument: reference data for users. Qual Life Res. 2002 Mar;11(2):173-83. doi: 10.1023/a:1015005109731.
- Individual participant dataSharing planned: No
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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.
Halit Ozel principal investigator
CHU Brugmann
Pierre Wauthy, MD study director
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MacNew questionnaire in people with Congenital Heart Disease, run by Pierre Wauthy at 1 site in Belgium.
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 1 inclusion and 1 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 22 Nov 2017. 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 Belgium. 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?
MacNew questionnaire (time frame: 30 minutes). 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 NCT03050112, which also lists 8 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 22 Nov 2017.