NCT02432092

Brief Summary

The goal of this protocol is to obtain information from individuals with cardiomyopathy and from their families in order to elucidate the molecular genetics of this disorder. This will provide the basis for future genetic counseling as well as contribute to elucidating the biology of normal and abnormal cardiac function.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress72%
Apr 2014Dec 2030

Study Start

First participant enrolled

April 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
15.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

16.8 years

First QC Date

April 28, 2015

Last Update Submit

June 23, 2025

Conditions

CardiomyopathiesDilated CardiomyopathyHypertrophic CardiomyopathyRestrictive CardiomyopathyArrhythmogenic Right Ventricular CardiomyopathyLeft Ventricular Non-compaction Cardiomyopathy

Keywords

CardiomegalyCardiovascular DiseasesHeart DiseasesSystolic dysfunctionDiastolic dysfunctionVentricular hypertrophyHeart failure

Outcome Measures

Primary Outcomes (1)

  • Elucidate the molecular genetics of cardiomyopathy

    7 years

Study Arms (2)

Affected

participants with cardiomyopathy

Family Members of affected

Family members of participants with cardiomyopathy (can be affected or unaffected)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Families affected by cardiomyopathy

You may qualify if:

  • Subjects with cardiomyopathy
  • Family members of subjects with cardiomyopathy

You may not qualify if:

  • Subjects without cardiomyopathy
  • Family members of subjects without cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IU School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Saliva, Tissue

MeSH Terms

Conditions

CardiomyopathiesCardiomyopathy, DilatedCardiomyopathy, HypertrophicCardiomyopathy, RestrictiveArrhythmogenic Right Ventricular DysplasiaCardiomegalyCardiovascular DiseasesHeart DiseasesHeart Failure

Condition Hierarchy (Ancestors)

LaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Stephanie Ware, MD, PhD

    IU School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey Helvaty, BS, BA

CONTACT

(317) 278-3020lhelvaty@iu.edu

Stephanie Ware, MD, PhD

CONTACT

(317) 278-2807stware@iu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Medical and Molecular Genetics

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 1, 2015

Study Start

April 1, 2014

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

June 26, 2025

Record last verified: 2025-06

Locations

US(1)