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Sahlgrenska Cardiomyopathy Project

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ClinicalTrials.gov Identifier: NCT03527342
Recruitment Status : Enrolling by invitation
First Posted : May 17, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Göteborg University

Brief 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

Condition or disease
Dilated Cardiomyopathies Hypertrophic Cardiomyopathy Restrictive Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathy Myocarditis Sarcoidosis With Myocarditis Giant Cell Myocarditis Amyloidosis; Heart (Manifestation)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Sahlgrenska University Hospital Cardiomyopathy Project: Mapping and Diagnosis of Cardiomyopathies to Enable Early and Specific Treatment
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2029


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



Primary Outcome Measures :
  1. Time to disease progression [ Time Frame: 2018-2028 ]

Other Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients are all patients referred to Sahlgrenska University Hospital, Gothenburg, Sweden with a cardiomyopathy diagnose.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527342


Locations
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Sweden
Göteborg University, Sahlgrenska Universitetssjukhuset
Göteborg, Sweden
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden

Additional Information:

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03527342     History of Changes
Other Study ID Numbers: SUCARD
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Cardiomyopathy, Dilated
Myocarditis
Arrhythmogenic Right Ventricular Dysplasia
Cardiomyopathy, Restrictive
Sarcoidosis
Amyloidosis
Heart Diseases
Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Cardiomegaly
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities