Heart Function and Exercise Capacity in Patients With Hypertrophic Cardiomyopathy

NCT ID: NCT00354328

Last Updated: 2018-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-27

Study Completion Date

2013-10-22

Brief Summary

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This study will examine the relationship between certain measures of heart function and exercise capacity in patients with hypertrophic cardiomyopathy (HCM).

Patients who participated in NHLBI studies 01-H-0006 ("Double Blind Placebo-Controlled Study of Pirfenidone - A Novel Anti-Fibrotic Drug - in Symptomatic Patients with Hypertrophic Cardiomyopathy Associated with Left Ventricular Diastolic Dysfunction") and 96-H-0144 ("Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin-Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced Left Ventricular Diastolic Dysfunction") are eligible for this study. Data from echocardiograms and measures of left ventricular pressure obtained from patients in those studies will be analyzed in the current study to assess their influence on exercise capacity. No additional tests, treatments or other procedures are required.

Information from this study may help in the development of improved drug treatments for HCM.

Detailed Description

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NIH Protocols 01-H-0066, Double Blind Placebo Controlled Study of Pirfenidone A Novel Anti-Fibrotic Drug in Symptomatic patients with Hypertrophic Cardiomyopathy (HCM) Associated with left Ventricular Diastolic Dysfunction and 96-H-0144, Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) On Genetically-Induced Left Ventricular Diastolic Dysfunction were undertaken to assess the effect of therapeutic interventions on left ventricular (LV) diastolic function. The relationship between baseline measures of diastolic function as assessed by noninvasive modalities such as Doppler echocardiography and radionuclide angiography, and qualitative and objective measures of functional capacity in patients without LV outflow tract obstruction has not been reported. In this protocol we will look at measures of LV geometry, relaxation and novel indices of ventricular compliance as they may influence measures of exercise capacity. In all cases, we will use pre-existing baseline data obtained with informed consent as part of the above protocols.

Conditions

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Angina, Unstable Myocardial Infarction Ischemic Heart Disease

Eligibility Criteria

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Inclusion Criteria

* Eligibility criteria not listed; Analysis of data from previous studies.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Principal Investigators

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Dorothea R McAreavey, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institutes of Health Clinical Center (CC)

Locations

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National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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05-H-0163

Identifier Type: -

Identifier Source: secondary_id

050163

Identifier Type: -

Identifier Source: org_study_id

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