Cardiomyopathy, DilatedPREDICT-DCMNCT03224156
Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy
An observational study of Cardiomyopathy, Dilated and Sudden Cardiac Death, run by University Hospital Heidelberg at 2 sites in Germany.
Trial summary
PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiomyopathy, Dilated, Sudden Cardiac Death
- What is being tested?
- Cardiac Magnetic Resonance Imaging
- How many people
- 150 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2017to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Dilated Cardiomyopathy prior to ICD-implantation.
Who may be able to join
- Dilated Cardiomyopathy
- ICD Indication
- age ≥ 18 years
- signed informed consent
Who cannot join
- severe claustrophobia
- rest dyspnea
- tachycardia or severe arrhythmia
- intolerance to gadolinium-based contrast agent
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Heidelberg, Krehl Klinik, Department of Cardiology
Heidelberg, Baden-Wurttemberg, 69120
Marco M Ochs, Dr. med.
- Not yet recruiting
GRN Hospital Weinheim
Weinheim, Baden-Wurttemberg, 69469
Sorin Giusca, Dr. med.
About this study
Official title: Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy: The PREDICT-DCM Trial.
PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.
Read the detailed description
Prophylactic ICD implantation was recently found to be non-beneficial over usual clinical care in non-ischemic systolic heart failure (LVEF≤35%) and 60-70% percent of SCD cases even occur in individuals with LEVF>35%. A growing evidence, that emphasizes the urgent need to improve the prediction of sudden cardiac death (SCD) in dilated cardiomyopathy (DCM).
CMR provides unique information on myocardial mechanics, fibrotic burden, inflammation and microvascular dysfunction, thereby allowing to quantify key substrates for myocardial arrhythmogenic potential.
PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.
Acquired candidate predictors are among others:
- Global and regional T1/T2
- T1/T2 inhomogeneity
- Extracellular volume fraction
- Microvascular dysfunction
- LA function and filling fraction
- Global and regional circumferential, radial or longitudinal myocardial strain
- Biomarkers
- Conditions
- Cardiomyopathy, Dilated, Sudden Cardiac Death
- Being tested
- Cardiac Magnetic Resonance Imaging
- Medical subject headings
- Cardiomyopathy, Dilated, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance ImagingDiagnostic test
Patients undergo baseline characterisation including CMR, ECG, blood samples prior to ICD implantation.
| Study group | Role | What they receive |
|---|---|---|
| Dilated Cardiomyopathy | Not described Receives: Diagnostic Test: Cardiac Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Combined Endpoint
Sudden Cardiac Death OR sustained VT OR non-sustained, long run VT
Measured: 18 months
Secondary outcomes (1)
Mortality
Cardiac Death
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, DilatedStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ochs, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224156
- Sponsor's protocol ID
- S-281/2017
- Acronym
- PREDICT-DCM
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy: The PREDICT-DCM Trial.
- ClinicalTrials.gov ID
- NCT03224156
- Acronym / sponsor ID
- PREDICT-DCM / S-281/2017
- Conditions
- Cardiomyopathy, Dilated, Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 21 Jul 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.
PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.
Detailed description
Prophylactic ICD implantation was recently found to be non-beneficial over usual clinical care in non-ischemic systolic heart failure (LVEF≤35%) and 60-70% percent of SCD cases even occur in individuals with LEVF>35%. A growing evidence, that emphasizes the urgent need to improve the prediction of sudden cardiac death (SCD) in dilated cardiomyopathy (DCM).
CMR provides unique information on myocardial mechanics, fibrotic burden, inflammation and microvascular dysfunction, thereby allowing to quantify key substrates for myocardial arrhythmogenic potential.
PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.
Acquired candidate predictors are among others:
- Global and regional T1/T2
- T1/T2 inhomogeneity
- Extracellular volume fraction
- Microvascular dysfunction
- LA function and filling fraction
- Global and regional circumferential, radial or longitudinal myocardial strain
- Biomarkers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dilated Cardiomyopathy | – | Diagnostic Test: Cardiac Magnetic Resonance Imaging |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Dilated Cardiomyopathy prior to ICD-implantation.
Key inclusion criteria (4 listed)
- Dilated Cardiomyopathy
- ICD Indication
- age ≥ 18 years
- signed informed consent
Key exclusion criteria (4 listed)
- severe claustrophobia
- rest dyspnea
- tachycardia or severe arrhythmia
- intolerance to gadolinium-based contrast agent
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 |
|---|---|---|
| Cardiac Magnetic Resonance ImagingPatients undergo baseline characterisation including CMR, ECG, blood samples prior to ICD implantation. | Diagnostic test | Dilated Cardiomyopathy |
Primary outcome
Primary Combined Endpoint
Time frame: 18 months
Sudden Cardiac Death OR sustained VT OR non-sustained, long run VT
1 secondary outcome
Mortality
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- University Hospital HeidelbergLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiomyopathy, Dilated
RecruitingPhase 2/3
A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy
RecruitingPhase 3
A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy (DCM)
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, Dilated and Sudden Cardiac Death, run by University Hospital Heidelberg at 2 sites in Germany.
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 4 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Marco M Ochs, Dr. med. (00496221-568611, marco.ochs@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Combined Endpoint (time frame: 18 months). 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 27 Jul 2017.