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NCT00354328 Clinical Trial

Heart Function and Exercise Capacity in Patients With Hypertrophic Cardiomyopathy

Myocardial Infarction Clinical Trial

Official title:
Relationship of Diastolic Function and Functional Capacity in Hypertrophic Cardiomyopathy: A Post-Hoc Analysis of Protocols 01-H-0066 and 96-H-0144

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00354328
Other study ID # 050163
Secondary ID 05-H-0163
Status Completed
Phase
First received
Last updated
Start date May 27, 2005
Est. completion date October 22, 2013

Study information
Verified date October 2017
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date October 22, 2013
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility - Eligibility criteria not listed; Analysis of data from previous studies.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)
Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

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