Heart DiseaseNCT00001746

Screening for Inherited Heart Disease

An observational study of Heart Disease and Hypertrophic Cardiomyopathy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Genetically inherited heart diseases like hypertrophic cardiomyopathy (HCM) are conditions affecting the heart passed on to family members by abnormalities in genetic information. These conditions are responsible for many heart related deaths and illnesses. Read more about this study

Who is it for?: Any age
Conditions the study is for: Heart Disease, Hypertrophic Cardiomyopathy
How many people: Not given
Where: 1 siteUnited States
Study dates: Apr 1998to Apr 2003
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

Who may be able to join

Subjects and family members known or suspected to have inherited a cardiac disease such as HCM.

Who cannot join

Patients with cardiac conditions that are not known to be inherited.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Evaluation of Patients With Known or Suspected Inherited Heart Disease (Screening Protocol)

Presently, there are several research studies being conducted in order to improve the understanding of disease processes and symptoms associated with genetically inherited heart diseases.

This study is designed to determine the eligibility of patients diagnosed with or suspected to have inherited heart disease to participate in these research studies.

Read the detailed description

Patients with hypertrophic cardiomyopathy (HCM) and other inherited cardiac diseases are being studied under several research protocols to determine their pathogenesis and clinical manifestations. The purpose of this protocol is to determine the eligibility of patients with known or suspected inherited heart conditions for our research protocols.

Conditions: Heart Disease, Hypertrophic Cardiomyopathy
Keywords: Hypertrophic Cardiomyopathy, HCM, Evaluation for Research, Medical Advice
Medical subject headings: Heart Diseases, Cardiomyopathy, Hypertrophic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 1998Apr 2003

First posted4 Nov 1999 (estimated)
Study startApr 1998
Study completionApr 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Heart DiseaseStudies of the same condition, open and under way.
More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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

IDs, dates and publications

ClinicalTrials.gov ID: NCT00001746
Sponsor's protocol ID: 980102
Other IDs: 98-H-0102
Status last verified: Apr 2003
First submitted: 3 Nov 1999
Last updated: 5 Mar 2008
Results posted: No

Publications

Maron BJ, Bonow RO, Cannon RO 3rd, Leon MB, Epstein SE. Hypertrophic cardiomyopathy. Interrelations of clinical manifestations, pathophysiology, and therapy (1). N Engl J Med. 1987 Mar 26;316(13):780-9. doi: 10.1056/NEJM198703263161305. No abstract available.
PubMed 3547130
Wigle ED, Rakowski H, Kimball BP, Williams WG. Hypertrophic cardiomyopathy. Clinical spectrum and treatment. Circulation. 1995 Oct 1;92(7):1680-92. doi: 10.1161/01.cir.92.7.1680.
PubMed 7671349
Solomon SD, Jarcho JA, McKenna W, Geisterfer-Lowrance A, Germain R, Salerni R, Seidman JG, Seidman CE. Familial hypertrophic cardiomyopathy is a genetically heterogeneous disease. J Clin Invest. 1990 Sep;86(3):993-9. doi: 10.1172/JCI114802.
PubMed 1975599

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening

All Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Patients With Known or Suspected Inherited Heart Disease (Screening Protocol)
ClinicalTrials.gov ID: NCT00001746
Acronym / sponsor ID: 980102
Conditions: Heart Disease, Hypertrophic Cardiomyopathy
Keywords: Hypertrophic Cardiomyopathy, HCM, Evaluation for Research, Medical Advice
Study type: Observational
Recruitment status: Completed
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
Study start: Apr 1998
Study completion: Apr 2003
First posted: 4 Nov 1999 (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.

Presently, there are several research studies being conducted in order to improve the understanding of disease processes and symptoms associated with genetically inherited heart diseases.

This study is designed to determine the eligibility of patients diagnosed with or suspected to have inherited heart disease to participate in these research studies.

Detailed description

Study design

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Subjects and family members known or suspected to have inherited a cardiac disease such as HCM.

Key exclusion criteria (1 listed)

Patients with cardiac conditions that are not known to be inherited.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2008.
Background: PubMed 3547130Maron BJ, Bonow RO, Cannon RO 3rd, Leon MB, Epstein SE. Hypertrophic cardiomyopathy. Interrelations of clinical manifestations, pathophysiology, and therapy (1). N Engl J Med. 1987 Mar 26;316(13):780-9. doi: 10.1056/NEJM198703263161305. No abstract available.
Background: PubMed 7671349Wigle ED, Rakowski H, Kimball BP, Williams WG. Hypertrophic cardiomyopathy. Clinical spectrum and treatment. Circulation. 1995 Oct 1;92(7):1680-92. doi: 10.1161/01.cir.92.7.1680.
Background: PubMed 1975599Solomon SD, Jarcho JA, McKenna W, Geisterfer-Lowrance A, Germain R, Salerni R, Seidman JG, Seidman CE. Familial hypertrophic cardiomyopathy is a genetically heterogeneous disease. J Clin Invest. 1990 Sep;86(3):993-9. doi: 10.1172/JCI114802.

Related trials for Heart Disease

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Heart Disease and Hypertrophic Cardiomyopathy, run by National Heart, Lung, and Blood Institute (NHLBI) 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 1 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: finished, as of the sponsor's last update on 5 Mar 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 NCT00001746, which also lists 3 linked publications.

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 5 Mar 2008.