Clinical trial NCT00354328: Heart Function and Exercise Capacity in Patients With Hypertrophic Cardiomyopathy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angina, Unstable
Myocardial Infarction
Ischemic Heart Disease
Keywords: HCM
Echocardiography
Diastolic Dysfunction
Enalapril
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-07-20
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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 criteria: * Eligibility criteria not listed; Analysis of data from previous studies.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Dorothea R McAreavey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: