German Centre for Cardiovascular Research Cardiomyopathy... | NCT02187263

Studies
German Centre for Cardiovascular Research Cardiomyopathy Register

NCT02187263

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Mar 25, 2016Estimated

Enrollment

2,300Estimated

Phase

Not provided

Conditions

Acute Myocarditis
Dilated Cardiomyopathies
Hypertrophic Cardiomyopathies
Left Ventricular Myocardial Noncompaction Cardiomyopathy
Arrhythmogenic Right Ventricular Cardiomyopathies
Amyloidosis

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jul 8, 2014

First Submission Date that Met QC Criteria

Jul 9, 2014

First Posted Date

Jul 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2016

Last Update Posted Date

Mar 25, 2016Estimated

Name	Class
Kerckhoff Klinik	OTHER
University Hospital Goettingen	OTHER
University of Hamburg-Eppendorf	OTHER
University of Kiel

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a joint project by Heidelberg University and Greifswald University.

Our objective is to establish an unique national multi-center registry and biobank of well phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical, molecular and omics-based phenotyping to serve as:

central hub for clinical outcome studies.
joint resource for diagnostic and therapeutic trials.
common biomaterial bank.
resource for detailed molecular analyses on patients' biomaterials and patient specific model systems.

Detailed Description

The following basic research projects, called modules, will be tied to and rely on the recruitment of CMP patients and the infrastructure provided by TORCH:

Well phenotyped patients will be the starting point for comprehensive next-generation genotyping, leading to advanced estimates of genotype-phenotype relationship and its clinical impact.
Functional analysis of novel genomic loci and their related molecular pathways will be based on our established in-vitro (e.g. iPS cells, yeast two hybrid) and in-vivo (e.g. zebrafish and mice) model systems.
The integrated analysis of viral load and replication, inflammation, genotype and clinical variables will define risk variables for inflammatory and hereditary CMP.
By longitudinal follow-up of patients, the role of genetic, epigenetic, metabolic, molecular biomarkers and histopathology for diagnosis and out-come prediction will be defined on a national level.

The registry will also facilitate investigator initiated clinical trials.

Conditions Module

Conditions

Acute Myocarditis
Dilated Cardiomyopathies
Hypertrophic Cardiomyopathies
Left Ventricular Myocardial Noncompaction Cardiomyopathy
Arrhythmogenic Right Ventricular Cardiomyopathies
Amyloidosis

Keywords

hereditary cardiomyopathy,
inflammatory cardiomyopathy,
registry,
biomaterial,
clinical trial
Patients

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,300Estimated

Measure	Description	Time Frame
Time to Disease Progression		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with primary non-ischemic cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, left ventricular non-compaction cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and acute myocarditis.

Exclusion Criteria:

Preexisting other cardiac diseases such as significant valvular, ischemic or pericardial disease; Severe arterial hypertension; Primary pulmonary artery hypertension; Chronic advanced disorders; History of treatment with cardiotoxic agents and chest radiation; Drug and alcohol abuse; Patients <18 and >79 years of age; Life expectancy less than 1 year due to non-cardiac comorbidity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with hereditary and inflammatory cardiomyopathies

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugo A Katus, MD	Heidelberg University	Study Chair
Wolfgang Hoffmann, MD	Department for Community Medicine, University Medicine Greifswald	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Heidelberg	Recruiting	Heidelberg			Germany

Condition Browse Module

MeSH Terms

ID	Term
D002311	Cardiomyopathy, Dilated
D002312	Cardiomyopathy, Hypertrophic
D000686	Amyloidosis

Ancestor Terms

ID	Term
D006332	Cardiomegaly
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009202	Cardiomyopathies

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
hereditary DCM
inflammatory DCM
LVNC
HCM
ARVC
acute myocarditis