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Heart Function and Exercise Capacity in Patients With Hypertrophic Cardiomyopathy
This study has been completed.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00354328
  Purpose

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.


Condition
Angina, Unstable
Myocardial Infarction
Ischemic Heart Disease

MedlinePlus related topics: Angina Cardiomyopathy Exercise and Physical Fitness Heart Attack Heart Diseases
Drug Information available for: Enalapril Enalapril maleate Enalaprilat
U.S. FDA Resources
Study Type: Observational
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

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 90
Study Start Date: May 2005
Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Eligibility criteria not listed; Analysis of data from previous studies.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354328

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Study ID Numbers: 050163, 05-H-0163
Study First Received: July 18, 2006
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00354328  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
HCM
Echocardiography
Diastolic Dysfunction
Enalapril

Study placed in the following topic categories:
Heart Diseases
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Constriction, Pathologic
Pain
Aortic valve stenosis
Ischemia
Cardiomyopathies
Heart Valve Diseases
Chest Pain
Signs and Symptoms
Enalapril
Necrosis
Hypertrophy
Enalaprilat
Cardiomyopathy, Hypertrophic
Aortic Valve Stenosis
Infarction
Myocardial Infarction
Angina, Unstable

Additional relevant MeSH terms:
Pathologic Processes
Aortic Stenosis, Subvalvular
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009