Viewing Study NCT00354328



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Last Modification Date: 2024-10-26 @ 9:26 AM
Study NCT ID: NCT00354328
Status: COMPLETED
Last Update Posted: 2018-10-05
First Post: 2006-07-18

Brief Title: Heart Function and Exercise Capacity in Patients With Hypertrophic Cardiomyopathy
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Institutes of Health Clinical Center CC

Study Overview

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
Status: COMPLETED
Status Verified Date: 2017-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
05-H-0163 None None None