Diastolic DysfunctionNCT06029192
Diastolic Function in Myotonic Dystrophy Type 1
An observational study of Diastolic Dysfunction, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Myotonic dystrophy type 1 (DM1) is a neuromuscular disorder in relation with an unstable expansion of CTG repeat. Patients with DM1 are at risk of arrhythmia and conduction disorders. Mortality are mainly related to respiratory failure and sudden death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diastolic Dysfunction
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2023to 1 Nov 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients with myotonic dystrophy type 1 followed in a tertiary reference center.
Who may be able to join
- patients with genetic proven myotonic dystrophy type 1
- who experienced a Doppler- Echocardiography including an assessment of the left ventricular diastolic function
Who cannot join
- wall motion basal abnormalities
- significant valvular disease
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Raymond Poincare
Garches, 92380
ABDALLAH FAYSSOIL, MDPhD, 003347101411, abdallah.fayssoil@aphp.fr
About this study
Myotonic dystrophy type 1 (DM1) is a neuromuscular disorder in relation with an unstable expansion of CTG repeat. Patients with DM1 are at risk of arrhythmia and conduction disorders. Mortality are mainly related to respiratory failure and sudden death. Patients with DM1 may suffer from obesity, arterial hypertension, diabetes mellitus and sleep apnea. These comorbidities are classically associated with left ventricular diastolic dysfunction (DD) .
The investigators aim to assess the prevalence of left ventricular diastolic dysfunction in patients with myotonic dystrophy type 1 , the distribution of DD grading as well as the long-term prognosis of DM1 patients with a left ventricular diastolic dysfunction.
- Conditions
- Diastolic Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 7 years
Secondary outcomes (2)
Incidence of arrhythmia
Measured: 7 years
acute heart failure
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start2 Jun 2023
- Primary completion2 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic DysfunctionStudies 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah FAYSSOIL, Centre d'Investigation Clinique et Technologique 805
- Investigators
- Abdallah FAYSSOIL, MD PhD, Principal investigator, CHU Raymond Poincare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029192
- Sponsor's protocol ID
- ECHO-DM1
- Status last verified
- Sep 2023
- First submitted
- 21 Jul 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Function in Myotonic Dystrophy Type 1
- ClinicalTrials.gov ID
- NCT06029192
- Acronym / sponsor ID
- ECHO-DM1
- Conditions
- Diastolic Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 2 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 8 Sep 2023 (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.
Myotonic dystrophy type 1 (DM1) is a neuromuscular disorder in relation with an unstable expansion of CTG repeat. Patients with DM1 are at risk of arrhythmia and conduction disorders. Mortality are mainly related to respiratory failure and sudden death. Patients with DM1 may suffer from obesity, arterial hypertension, diabetes mellitus and sleep apnea. These comorbidities are classically associated with left ventricular diastolic dysfunction (DD) .
The investigators aim to assess the prevalence of left ventricular diastolic dysfunction in patients with myotonic dystrophy type 1 , the distribution of DD grading as well as the long-term prognosis of DM1 patients with a left ventricular diastolic dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with myotonic dystrophy type 1 followed in a tertiary reference center.
Key inclusion criteria (2 listed)
- patients with genetic proven myotonic dystrophy type 1
- who experienced a Doppler- Echocardiography including an assessment of the left ventricular diastolic function
Key exclusion criteria (2 listed)
- wall motion basal abnormalities
- significant valvular disease
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
mortality
Time frame: 7 years
2 secondary outcomes
Incidence of arrhythmia
Time frame: 7 years
acute heart failure
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- 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.
Abdallah FAYSSOIL, MD PhD principal investigator
CHU Raymond Poincare
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 Diastolic Dysfunction, run by Centre d'Investigation Clinique et Technologique 805 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 2 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 8 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdallah FAYSSOIL, MD PhD (+33147107778, abdallah.fayssoil@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2023.