Dilated CardiomyopathyBecker-HSNCT02020954
Prospective Becker-Heart-Study
An observational study of Dilated Cardiomyopathy and Lef Ventricular Dysfunction, run by Karim WAHBI at 1 site in France.
Trial summary
The purpose of this study is to determine whether electrocardiogram, echocardiography, cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and clinical outcome. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Dilated Cardiomyopathy, Lef Ventricular Dysfunction, Heart Failure
- What is being tested?
- ECG, echocardiography, cardiac MRI, sera biomarkers
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Jun 2017
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy
Who may be able to join
- mutation in the DMD gene
- Becker muscular dystrophy and/or dilated cardiomyopathy
- age>18 years
- affiliation to the French medical insurance
Who cannot join
- Duchenne muscular dystrophy
- Any other chronic disease that may be associated with heart disease
Trial locations and contacts
1 site in 1 country.
Karim Wahbi, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Institut de Myologie
Paris, Île-de-France Region, 75013
Nawal Berber, PhD, n.benammar@institut-myologie.org
Karim Wahbi, MD, PhD
About this study
Official title: Prospective Cohort Study of Patients With Mutations in the Dystrophin Gene (X Linked Dilated Cardiomyopathy and Becker Muscular Dystrophy)
The purpose of this study is to determine whether electrocardiogram, echocardiography, cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and clinical outcome.
Read the detailed description
A cohort of 100 patients with mutations in the dystrophin gene associated with Becker muscular dystrophy and/or dilated cardiomyopathy will be included (patients with Duchenne muscular dystrophy are excluded).
Patients with undergo at baseline the following workups: electrocardiogram, echocardiography, cardiac MRI, sera biomarkers measurement.
At 3 years and 5 years, patients will be investigated according to the same protocol and occurrence of cardiac adverse events in the meanwhile will be recorded.
Statistical analysis will assess correlations between cardiac phenotype and DMD mutations and prognostic value of cardiac investigations.
- Being tested
- ECG, echocardiography, cardiac MRI, sera biomarkers
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG, echocardiography, cardiac MRI, sera biomarkersProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Dystrophinopathy | Patients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy Receives: Procedure: ECG, echocardiography, cardiac MRI, sera biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
Measured: 3 years
Secondary outcomes (1)
Composite endpoint: hospitalisation for heart failure, death due to heart failure
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karim WAHBI
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Myologie, France
- Responsible party
- Sponsor-investigator, Karim WAHBI, Institut de Myologie, France
- Investigators
- Karim Wahbi, MD, PhD, Principal investigator, Institut de Myologie, Cochin Hospital, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020954
- Sponsor's protocol ID
- Becker-Heart-Study
- Acronym
- Becker-HS
- Status last verified
- Mar 2015
- First submitted
- 19 Dec 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marty B, Baudin PY, Caldas de Almeida Araujo E, Fromes Y, Wahbi K, Reyngoudt H. Assessment of Extracellular Volume Fraction in Becker Muscular Dystrophy by Using MR Fingerprinting. Radiology. 2023 May;307(3):e221115. doi: 10.1148/radiol.221115. Epub 2023 Mar 7.
PubMed 36880945
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Patients With Mutations in the Dystrophin Gene (X Linked Dilated Cardiomyopathy and Becker Muscular Dystrophy)
- ClinicalTrials.gov ID
- NCT02020954
- Acronym / sponsor ID
- Becker-HS / Becker-Heart-Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karim WAHBIUniversity, hospital or other
- Collaborators
- Institut de Myologie, France
- Study start
- Jan 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 25 Dec 2013 (estimated)
- 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.
The purpose of this study is to determine whether electrocardiogram, echocardiography, cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and clinical outcome.
Detailed description
A cohort of 100 patients with mutations in the dystrophin gene associated with Becker muscular dystrophy and/or dilated cardiomyopathy will be included (patients with Duchenne muscular dystrophy are excluded).
Patients with undergo at baseline the following workups: electrocardiogram, echocardiography, cardiac MRI, sera biomarkers measurement.
At 3 years and 5 years, patients will be investigated according to the same protocol and occurrence of cardiac adverse events in the meanwhile will be recorded.
Statistical analysis will assess correlations between cardiac phenotype and DMD mutations and prognostic value of cardiac investigations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dystrophinopathy | – | Procedure: ECG, echocardiography, cardiac MRI, sera biomarkersPatients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy
Key inclusion criteria (4 listed)
- mutation in the DMD gene
- Becker muscular dystrophy and/or dilated cardiomyopathy
- age>18 years
- affiliation to the French medical insurance
Key exclusion criteria (2 listed)
- Duchenne muscular dystrophy
- Any other chronic disease that may be associated with heart disease
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 |
|---|---|---|
| ECG, echocardiography, cardiac MRI, sera biomarkers | Procedure or surgery | Dystrophinopathy |
Primary outcome
Left ventricular ejection fraction
Time frame: 3 years
1 secondary outcome
Composite endpoint: hospitalisation for heart failure, death due to heart failure
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Derived from this study: PubMed 36880945Marty B, Baudin PY, Caldas de Almeida Araujo E, Fromes Y, Wahbi K, Reyngoudt H. Assessment of Extracellular Volume Fraction in Becker Muscular Dystrophy by Using MR Fingerprinting. Radiology. 2023 May;307(3):e221115. doi: 10.1148/radiol.221115. Epub 2023 Mar 7.
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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.
Karim Wahbi, MD, PhD contact
Karim Wahbi, MD, PhD principal investigator
Institut de Myologie, Cochin Hospital, Paris
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 Dilated Cardiomyopathy and Lef Ventricular Dysfunction, run by Karim WAHBI 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Mar 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karim Wahbi, MD, PhD (karim.wahbi@cch.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (time frame: 3 years). 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 NCT02020954, which also lists 1 linked publication.
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 24 Mar 2015; AzTrials last refreshed its copy on 27 Oct 2026.