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Enrolling by Invitation

NCT Number: NCT03527342

Sahlgrenska Cardiomyopathy Project

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

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Key information

Conditions

Dilated Cardiomyopathies Amyloidosis Amyloidosis; Heart (Manifestation) Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Arrhythmogenic Right Ventricular Cardiomyopathy Arrhythmogenic Right Ventricular Dysplasia Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Restrictive Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Giant Cell Myocarditis Heart Defects, Congenital Heart Diseases Heart Valve Diseases Hypertrophic Cardiomyopathy Laminopathies Metabolic Diseases Myocarditis Nutritional and Metabolic Diseases Proteostasis Deficiencies Restrictive Cardiomyopathy Sarcoidosis With Myocarditis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Göteborg University, Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to disease progression

    Time frame: 2018-2028

Other outcomes

  1. Progression in biomarker NT-proBNP

    Time frame: 2018-2028

  2. Changes over time in presence of autoantibodies

    Time frame: 2018-2028

  3. Disease activity evaluated by positron-emissions-tomography computed tomography (PET-CT)

    Time frame: 2018-2028

  4. Disease activity evaluated by magnetic resonance imaging (MRI)

    Time frame: 2018-2028

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
May 17, 2018
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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