NCT03224156

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

July 18, 2017

Last Update Submit

July 25, 2017

Conditions

Cardiomyopathy, DilatedSudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

  • Primary Combined Endpoint

    Sudden Cardiac Death OR sustained VT OR non-sustained, long run VT

    18 months

Secondary Outcomes (1)

  • Mortality

    18 months

Study Arms (1)

Dilated Cardiomyopathy

Diagnostic Test: Cardiac Magnetic Resonance Imaging

Interventions

Cardiac Magnetic Resonance ImagingDIAGNOSTIC_TEST

Patients undergo baseline characterisation including CMR, ECG, blood samples prior to ICD implantation.

Dilated Cardiomyopathy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with Dilated Cardiomyopathy prior to ICD-implantation.

You may qualify if:

  • Dilated Cardiomyopathy
  • ICD Indication
  • age ≥ 18 years
  • signed informed consent

You may not qualify if:

  • severe claustrophobia
  • rest dyspnea
  • tachycardia or severe arrhythmia
  • intolerance to gadolinium-based contrast agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Heidelberg, Krehl Klinik, Department of Cardiology

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

GRN Hospital Weinheim

Weinheim, Baden-Wurttemberg, 69469, Germany

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Cardiomyopathy, DilatedDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart ArrestDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Marco M Ochs, Dr. med.

CONTACT

00496221-568611marco.ochs@med.uni-heidelberg.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Marco Ochs

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations

DE(2)