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Heart Function and Exercise Capacity in Patients With Hypertrophic Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT00354328
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : October 5, 2018
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief 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.


Condition or disease
Angina, Unstable Myocardial Infarction Ischemic Heart Disease

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.

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Study Type : Observational
Actual Enrollment : 110 participants
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
Study Start Date : May 27, 2005
Study Completion Date : October 22, 2013






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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Eligibility criteria not listed; Analysis of data from previous studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354328


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Dorothea R McAreavey, M.D. National Institutes of Health Clinical Center (CC)

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ClinicalTrials.gov Identifier: NCT00354328     History of Changes
Other Study ID Numbers: 050163
05-H-0163
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2017
Keywords provided by National Institutes of Health Clinical Center (CC):
HCM
Echocardiography
Diastolic Dysfunction
Enalapril
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Infarction
Cardiomyopathies
Myocardial Ischemia
Coronary Artery Disease
Cardiomyopathy, Hypertrophic
Angina, Unstable
Infarction
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms