Sahlgrenska Cardiomyopathy Project

November 2, 2018 updated by: Göteborg University

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden
        • Göteborg University, Sahlgrenska Universitetssjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible patients are all patients referred to Sahlgrenska University Hospital, Gothenburg, Sweden with a cardiomyopathy diagnose.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Dilated Cardiomyopathy
Myocarditis
Sarcoidosis Heart
Giant Cell Myocarditis
Amyloidosis Heart
Hypertrophic Cardiomyopathies
Left Ventricular Myocardial Noncompaction Cardiomyopathy
Arrhythmogenic Right Ventricular Cardiomyopathies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to disease progression
Time Frame: 2018-2028
2018-2028

Other Outcome Measures

Outcome Measure
Time Frame
Progression in biomarker NT-proBNP
Time Frame: 2018-2028
2018-2028
Changes over time in presence of autoantibodies
Time Frame: 2018-2028
2018-2028
Disease activity evaluated by positron-emissions-tomography computed tomography (PET-CT)
Time Frame: 2018-2028
2018-2028
Disease activity evaluated by magnetic resonance imaging (MRI)
Time Frame: 2018-2028
2018-2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ANTICIPATED)

January 1, 2028

Study Completion (ANTICIPATED)

January 1, 2029

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (ACTUAL)

May 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUCARD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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