NCT03527342

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. 1.resource for diagnostic and therapeutic trials
  2. 2.common biomaterial bank
  3. 3.resource for detailed molecular analyses on patients' biomaterials and patient specific symptoms and examination results

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jun 2018Jan 2029

First Submitted

Initial submission to the registry

April 23, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

9.6 years

First QC Date

April 23, 2018

Last Update Submit

November 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to disease progression

    2018-2028

Other Outcomes (4)

  • Progression in biomarker NT-proBNP

    2018-2028

  • Changes over time in presence of autoantibodies

    2018-2028

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

    2018-2028

  • +1 more other outcomes

Study Arms (8)

Dilated Cardiomyopathy

Myocarditis

Sarcoidosis Heart

Giant Cell Myocarditis

Amyloidosis Heart

Hypertrophic Cardiomyopathies

Left Ventricular Myocardial Noncompaction Cardiomyopathy

Arrhythmogenic Right Ventricular Cardiomyopathies

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patient with other preexisting cardiac diseases such as significant valvular, ischemic or pericardial disease before they receive a cardiomyopathy diagnose
  • patients \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Göteborg University, Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Cardiomyopathy, DilatedCardiomyopathy, HypertrophicCardiomyopathy, RestrictiveArrhythmogenic Right Ventricular DysplasiaMyocarditisAmyloidosis

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 17, 2018

Study Start

June 1, 2018

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

November 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations