Cardiomyopathy, DilatedNCT02352129
Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy
A study testing CMR using T1 mapping technique in people with Cardiomyopathy, Dilated, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
: Fibrosis, in general, is a scarring process, which is characterized by fibroblast accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to distorted organ architecture and function. The contribution of fibrogenesis to impaired cardiac function is increasingly recognized. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy, Dilated
- What is being tested?
- CMR using T1 mapping technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient with dilated cardiomyopathy and typical symptoms of cardiac insufficiency at the time of the diagnosis: oedemas of lower limbs, dyspnoea, asthenia.
- and of a reduction in the fraction of ventricular ejection left (awkward) 45 % measured in echocardiography ( modified Simpson biplane) and associated with a volume télédiastolic volume superior to the normal in echocardiography: > 90ml / m2 ( modified Simpson biplane).
Who cannot join
- Patients to whom the dysfunction VG is secondary or in a secondary overload of pressures in a HTA or a severe valvulopathie is in a coronary infringement(achievement), proved by histories of infarct or gestures(movements) of revascularisation (bypass(decking), stent) and or coronary hurts at least bi tronculaires significant the severity of which can explain the ventriculaire failure.
Trial locations and contacts
1 site in 1 country.
About this study
: Fibrosis, in general, is a scarring process, which is characterized by fibroblast accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to distorted organ architecture and function. The contribution of fibrogenesis to impaired cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and induces pathological signaling within cardiomyocytes resulting in progressive cardiac failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and increases the risk of arrhythmias. But today patient treatment and prognosis is based on ejection fraction quantification, QRS duration, and symptoms.
Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared with normal value, is of prognostic value in patient with dilated cardiomyopathies under optimal treatment.
Methods: 330 patients are planned to be included and followed for 2 years
- Conditions
- Cardiomyopathy, Dilated
- Being tested
- CMR using T1 mapping technique
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMR using T1 mapping techniqueOther
the level of myocardial fibrosis for patient suffering of cardiomyopathy dilated will be quantified using CMR T1 mapping technique
| Study group | Role | What they receive |
|---|---|---|
| Cardiomyopathy dilated patient | Experimental | Cardiomyopathy dilated patients wil be evalueted by CMR using T1 mapping technique to evalueted the level myocardial fibrosis Receives: Other: CMR using T1 mapping technique |
| healthy subjects | Active comparator | healthy subject wil be evaluated by CMR using T1 mapping technique to know the baseline of myocardial fibrosis in healthy subjects Receives: Other: CMR using T1 mapping technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of the increased level of myocardial fibrosis
The long-term forecast of the patients affected by CMD will be estimated by the survival without event. The events considered in this study are included in an associating combined criterion:
- Death(Deaths), whatever is its cause.
- The heart transplant
- Hospitalization for cardiac cause, including acute(sharp) cardiac insufficiency, disorder(confusion) of the rhythm, required by rehabilitation of the treatment(processing), the thrombus ventriculaire left, cerebrovascular accident.
- Palpitation ventriculaire steady (ventriculaire extrasystole > 120 pulsation for minutes more than 30 on Holter of 24 hours(12 pm)).
- Palpitation ventriculaire not steady
Measured: two years
Secondary outcomes (1)
hemodynamic consequences of the increased level of myocardial fibrosis
The quantity of interstitial fibrosis at the time of the diagnosis will be correlated to the indicators of the reshaping left ventriculaire measured in echocardiography: decrease of more than 10 % of the fraction of ejection over 2 years or increase of the volume télédiastolique furthermore of 20ml / the year.
Measured: txw years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startDec 2011
- Primary completionJan 2017
- Study completionJun 2017
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 Cardiomyopathy, DilatedStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- alexis JACQUIER, MD, Principal investigator, Assistance Public Hôpitaux de marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352129
- Sponsor's protocol ID
- 2011-A00887-34
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2015
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Cadour F, Quemeneur M, Biere L, Donal E, Bentatou Z, Eicher JC, Roubille F, Lalande A, Giorgi R, Rapacchi S, Cortaredona S, Tradi F, Bartoli A, Willoteaux S, Delahaye F, Biene SM, Mangin L, Ferrier N, Dacher JN, Bauer F, Leurent G, Lentz PA, Kovacsik H, Croisille P, Thuny F, Bernard M, Guye M, Furber A, Habib G, Jacquier A. Prognostic value of cardiovascular magnetic resonance T1 mapping and extracellular volume fraction in nonischemic dilated cardiomyopathy. J Cardiovasc Magn Reson. 2023 Feb 6;25(1):7. doi: 10.1186/s12968-023-00919-y.
PubMed 36747201
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02352129
- Acronym / sponsor ID
- 2011-A00887-34
- Conditions
- Cardiomyopathy, Dilated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Feb 2015 (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.
: Fibrosis, in general, is a scarring process, which is characterized by fibroblast accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to distorted organ architecture and function. The contribution of fibrogenesis to impaired cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and induces pathological signaling within cardiomyocytes resulting in progressive cardiac failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and increases the risk of arrhythmias. But today patient treatment and prognosis is based on ejection fraction quantification, QRS duration, and symptoms.
Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared with normal value, is of prognostic value in patient with dilated cardiomyopathies under optimal treatment.
Methods: 330 patients are planned to be included and followed for 2 years
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiomyopathy dilated patient | Experimental | Other: CMR using T1 mapping techniqueCardiomyopathy dilated patients wil be evalueted by CMR using T1 mapping technique to evalueted the level myocardial fibrosis |
| healthy subjects | Active comparator | Other: CMR using T1 mapping techniquehealthy subject wil be evaluated by CMR using T1 mapping technique to know the baseline of myocardial fibrosis in healthy subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient with dilated cardiomyopathy and typical symptoms of cardiac insufficiency at the time of the diagnosis: oedemas of lower limbs, dyspnoea, asthenia.
- and of a reduction in the fraction of ventricular ejection left (awkward) 45 % measured in echocardiography ( modified Simpson biplane) and associated with a volume télédiastolic volume superior to the normal in echocardiography: > 90ml / m2 ( modified Simpson biplane).
Key exclusion criteria (1 listed)
- Patients to whom the dysfunction VG is secondary or in a secondary overload of pressures in a HTA or a severe valvulopathie is in a coronary infringement(achievement), proved by histories of infarct or gestures(movements) of revascularisation (bypass(decking), stent) and or coronary hurts at least bi tronculaires significant the severity of which can explain the ventriculaire failure.
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 |
|---|---|---|
| CMR using T1 mapping techniquethe level of myocardial fibrosis for patient suffering of cardiomyopathy dilated will be quantified using CMR T1 mapping technique | Other | Cardiomyopathy dilated patient, healthy subjects |
Primary outcome
Prognostic value of the increased level of myocardial fibrosis
Time frame: two years
The long-term forecast of the patients affected by CMD will be estimated by the survival without event. The events considered in this study are included in an associating combined criterion: * Death(Deaths), whatever is its cause. * The heart transplant * Hospitalization for cardiac cause, including acute(sharp) cardiac insufficiency, disorder(confusion) of the rhythm, required by rehabilitation of the treatment(processing), the thrombus ventriculaire left, cerebrovascular accident. * Palpitation ventriculaire steady (ventriculaire extrasystole > 120 pulsation for minutes more than 30 on Holter of 24 hours(12 pm)). * Palpitation ventriculaire not steady
1 secondary outcome
hemodynamic consequences of the increased level of myocardial fibrosis
Time frame: txw years
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 8 May 2026.
- Results publication: PubMed 36747201Cadour F, Quemeneur M, Biere L, Donal E, Bentatou Z, Eicher JC, Roubille F, Lalande A, Giorgi R, Rapacchi S, Cortaredona S, Tradi F, Bartoli A, Willoteaux S, Delahaye F, Biene SM, Mangin L, Ferrier N, Dacher JN, Bauer F, Leurent G, Lentz PA, Kovacsik H, Croisille P, Thuny F, Bernard M, Guye M, Furber A, Habib G, Jacquier A. Prognostic value of cardiovascular magnetic resonance T1 mapping and extracellular volume fraction in nonischemic dilated cardiomyopathy. J Cardiovasc Magn Reson. 2023 Feb 6;25(1):7. doi: 10.1186/s12968-023-00919-y.
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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.
alexis JACQUIER, MD principal investigator
Assistance Public Hôpitaux de marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMR using T1 mapping technique in people with Cardiomyopathy, Dilated, run by Assistance Publique Hopitaux De Marseille 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 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 8 May 2026. 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?
Prognostic value of the increased level of myocardial fibrosis (time frame: two 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 NCT02352129, 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 8 May 2026.