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NCT03527342 Clinical Trial

Sahlgrenska Cardiomyopathy Project

Hypertrophic Cardiomyopathy Clinical Trial

Official title:
Sahlgrenska University Hospital Cardiomyopathy Project: Mapping and Diagnosis of Cardiomyopathies to Enable Early and Specific Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03527342
Other study ID # SUCARD
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date January 2029

Study information
Verified date November 2018
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is a joint project by Sahlgrenska University Hospital: Sahlgrenska, Östra and Mölndal.

Our objective is to diagnose and map patients with well phenotyped cardiomyopathies (CMP) including in depth clinical and molecular phenotyping to enable earlier and specific treatment. The project will serve as:

1. resource for diagnostic and therapeutic trials

2. common biomaterial bank

3. resource for detailed molecular analyses on patients' biomaterials and patient specific symptoms and examination results

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 3000
Est. completion date January 2029
Est. primary completion date January 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Patients with primary cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, left ventricular non-compaction cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, myocarditis, giant cell myocarditis, sarcoidosis and amyloidosis engaging the heart

Exclusion Criteria:

- Patient with other preexisting cardiac diseases such as significant valvular, ischemic or pericardial disease before they receive a cardiomyopathy diagnose

- patients < 18 years

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Göteborg University, Sahlgrenska Universitetssjukhuset Göteborg

Sponsors (2)
Lead Sponsor Collaborator
Göteborg University Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Other Progression in biomarker NT-proBNP 2018-2028
Other Changes over time in presence of autoantibodies 2018-2028
Other Disease activity evaluated by positron-emissions-tomography computed tomography (PET-CT) 2018-2028
Other Disease activity evaluated by magnetic resonance imaging (MRI) 2018-2028
Primary Time to disease progression 2018-2028
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