CardiomyopathiesNCT02432092
Pediatric Cardiomyopathy Mutation Analysis
An observational study of Cardiomyopathies and Dilated Cardiomyopathy, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiomyopathies, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Families affected by cardiomyopathy
Who may be able to join
- Subjects with cardiomyopathy
- Family members of subjects with cardiomyopathy
Who cannot join
- Subjects without cardiomyopathy
- Family members of subjects without cardiomyopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
IU School of Medicine
Indianapolis, Indiana, 46202
Stephanie Ware, MD, PhD, 317-278-2807, stware@iu.edu
About this study
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.
Read the detailed description
Cardiomyopathy is a genetically heterogeneous heart muscle disorder that results in ventricular dysfunction. While significant progress has been made in identifying the genetic basis of cardiomyopathy in adults, molecular diagnosis in children has proven more challenging and current algorithms do not incorporate mutation analysis in the clinical protocol. However, recent studies indicate that cardiomyopathy outcomes in children are origin specific, highlighting the importance of precise diagnosis. The goal of this study is to identify the genetic causes of pediatric cardiomyopathy. Rapid, comprehensive and cost-effective detection of genetic causes of cardiomyopathy will aid management and development of novel treatment strategies.
- Conditions
- Cardiomyopathies, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Restrictive Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Left Ventricular Non-compaction Cardiomyopathy
- Keywords
- Cardiomegaly, Cardiovascular Diseases, Heart Diseases, Systolic dysfunction, Diastolic dysfunction, Ventricular hypertrophy, Heart failure
- Medical subject headings
- Cardiomyopathies, Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Cardiomyopathy, Restrictive, Arrhythmogenic Right Ventricular Dysplasia, Cardiomegaly, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected | participants with cardiomyopathy | |
| Family Members of affected | Family members of participants with cardiomyopathy (can be affected or unaffected) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elucidate the molecular genetics of cardiomyopathy
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startApr 2014
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Stephanie Ware, Indiana University
- Investigators
- Stephanie Ware, MD, PhD, Principal investigator, IU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432092
- Sponsor's protocol ID
- 1403919054
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2015
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Cardiomyopathy Mutation Analysis
- ClinicalTrials.gov ID
- NCT02432092
- Acronym / sponsor ID
- 1403919054
- Conditions
- Cardiomyopathies, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Restrictive Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Left Ventricular Non-compaction Cardiomyopathy
- Keywords
- Cardiomegaly, Cardiovascular Diseases, Heart Diseases, Systolic dysfunction, Diastolic dysfunction, Ventricular hypertrophy, Heart failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Apr 2014
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiomyopathy is a genetically heterogeneous heart muscle disorder that results in ventricular dysfunction. While significant progress has been made in identifying the genetic basis of cardiomyopathy in adults, molecular diagnosis in children has proven more challenging and current algorithms do not incorporate mutation analysis in the clinical protocol. However, recent studies indicate that cardiomyopathy outcomes in children are origin specific, highlighting the importance of precise diagnosis. The goal of this study is to identify the genetic causes of pediatric cardiomyopathy. Rapid, comprehensive and cost-effective detection of genetic causes of cardiomyopathy will aid management and development of novel treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected | – | –participants with cardiomyopathy |
| Family Members of affected | – | –Family members of participants with cardiomyopathy (can be affected or unaffected) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Families affected by cardiomyopathy
Key inclusion criteria (2 listed)
- Subjects with cardiomyopathy
- Family members of subjects with cardiomyopathy
Key exclusion criteria (2 listed)
- Subjects without cardiomyopathy
- Family members of subjects without cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elucidate the molecular genetics of cardiomyopathy
Time frame: 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Ware, MD, PhD principal investigator
IU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies and Dilated Cardiomyopathy, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Murphy, MPH ((317) 278-3026, bankssk@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elucidate the molecular genetics of cardiomyopathy (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.