Dilated CardiomyopathyNCT00703443
The Genetics of Cardiomyopathy and Heart Failure
An observational study of Dilated Cardiomyopathy and Hypertrophic Cardiomyopathy, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to determine the genetic basis of cardiomyopathies and heart failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Mitochondrial Cardiomyopathy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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: We are recruiting both local participants (who have been evaluated at UCI) and remote participants (who have been referred from outside UCI) with familial and simplex cases of hypertrophic, dilated, noncompaction, restrictive, and mitochondrial cardiomyopathies. As a control group, we are also recruiting patients with nuclear mutations known to increase the risk of cardiomyopathy, but who have not themselves developed cardiomyopathy.
Who may be able to join
- Individuals with a diagnosis of cardiomyopathy
- Family members of individuals with a diagnosis of cardiomyopathy
- Individuals with a nuclear mutation shown to confer risk of cardiomyopathy but who do not themselves have cardiomyopathy
Who cannot join
- Individuals who do not have cardiomyopathy, a relative with cardiomyopathy, or a nuclear mutation predisposing to cardiomyopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
The purpose of this study is to determine the genetic basis of cardiomyopathies and heart failure.
Read the detailed description
The purpose of this research study is to explore the causes and inheritances of cardiomyopathies. Cardiomyopathies are serious medical conditions that result in a wide range of cardiac problems, from no symptoms at all to heart failure. The underlying genetics of cardiomyopathies are poorly understood. This study will collect personal, family, and medical history information to create a database of participants with cardiomyopathies. This information will be used to identify inheritance patterns within families with cardiomyopathies. In addition, samples from participants will be studied in the lab to see if any changes in their genetic information can be identified that would cause a cardiomyopathy. Overall, the research study is aimed at determining the cause of these cardiac conditions so that tests and treatments might be developed in the future.
- Conditions
- Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Mitochondrial Cardiomyopathy, Noncompaction Cardiomyopathy, Restrictive Cardiomyopathy
- Keywords
- Genetics, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Mitochondrial Cardiomyopathy, Noncompaction Cardiomyopathy, Restrictive Cardiomyopathy, Heart Failure
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Cardiomyopathy, Restrictive, Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: Non applicable clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael V Zaragoza, M.D., Ph.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703443
- Sponsor's protocol ID
- HS# 2007-5577
- Other IDs
- NIH/NHLBI 5K08HL081222-02
- Status last verified
- Jan 2021
- First submitted
- 19 Jun 2008
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Zaragoza MV, Arbustini E, Narula J. Noncompaction of the left ventricle: primary cardiomyopathy with an elusive genetic etiology. Curr Opin Pediatr. 2007 Dec;19(6):619-27. doi: 10.1097/MOP.0b013e3282f1ecbc.
PubMed 18025927
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genetics of Cardiomyopathy and Heart Failure
- ClinicalTrials.gov ID
- NCT00703443
- Acronym / sponsor ID
- HS# 2007-5577
- Conditions
- Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Mitochondrial Cardiomyopathy, Noncompaction Cardiomyopathy, Restrictive Cardiomyopathy
- Keywords
- Genetics, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Mitochondrial Cardiomyopathy, Noncompaction Cardiomyopathy, Restrictive Cardiomyopathy, Heart Failure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Non applicable clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 23 Jun 2008 (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 purpose of this study is to determine the genetic basis of cardiomyopathies and heart failure.
Detailed description
The purpose of this research study is to explore the causes and inheritances of cardiomyopathies. Cardiomyopathies are serious medical conditions that result in a wide range of cardiac problems, from no symptoms at all to heart failure. The underlying genetics of cardiomyopathies are poorly understood. This study will collect personal, family, and medical history information to create a database of participants with cardiomyopathies. This information will be used to identify inheritance patterns within families with cardiomyopathies. In addition, samples from participants will be studied in the lab to see if any changes in their genetic information can be identified that would cause a cardiomyopathy. Overall, the research study is aimed at determining the cause of these cardiac conditions so that tests and treatments might be developed in the future.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We are recruiting both local participants (who have been evaluated at UCI) and remote participants (who have been referred from outside UCI) with familial and simplex cases of hypertrophic, dilated, noncompaction, restrictive, and mitochondrial cardiomyopathies. As a control group, we are also recruiting patients with nuclear mutations known to increase the risk of cardiomyopathy, but who have not themselves developed cardiomyopathy.
Key inclusion criteria (3 listed)
- Individuals with a diagnosis of cardiomyopathy
- Family members of individuals with a diagnosis of cardiomyopathy
- Individuals with a nuclear mutation shown to confer risk of cardiomyopathy but who do not themselves have cardiomyopathy
Key exclusion criteria (1 listed)
- Individuals who do not have cardiomyopathy, a relative with cardiomyopathy, or a nuclear mutation predisposing to 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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Background: PubMed 18025927Zaragoza MV, Arbustini E, Narula J. Noncompaction of the left ventricle: primary cardiomyopathy with an elusive genetic etiology. Curr Opin Pediatr. 2007 Dec;19(6):619-27. doi: 10.1097/MOP.0b013e3282f1ecbc.
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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. This study is not recruiting at the moment.
Michael V Zaragoza, M.D., Ph.D. principal investigator
University of California, Irvine
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 Dilated Cardiomyopathy and Hypertrophic Cardiomyopathy, run by University of California, Irvine 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Jan 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00703443, which also lists 1 linked publication.
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 25 Jan 2021.