Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001534
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Long Term Effects of Enalapril and Losartan on Genetic Heart Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Double-Blind Placebo-Controlled Study of the Long Term Effects of Angiotensin Converting Enzyme Inhibition Enalapril and Angiotensin II Receptor Blockade Losartan on Genetically-Induced Left Ventricular Hypertrophy in Non-Obstructive HCM
Status:
COMPLETED
Status Verified Date:
2003-04
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:
The human heart is divided into four chambers One of the four chambers the left ventricle is the chamber mainly responsible for pumping blood out of the heart into circulation Hypertrophic cardiomyopathy HCM is a genetically inherited disease causing an abnormal thickening of the heart muscle especially the muscle making up the left ventricle When the left ventricle becomes abnormally large it is called left ventricular hypertrophy LVH This condition can cause symptoms of chest pain shortness of breath fatigue and heart beat palpitations
This study is designed to compare the ability of two drugs enalapril and losartan to improve symptoms and heart function of patients diagnosed with hypertrophic cardiomyopathy HCM
Researchers have decided to compare these drugs because each one has been used to treat patients with other diseases causing thickening of the heart muscle In these other conditions enalapril and losartan have improved symptoms decreased the thickness of heart muscle improved blood flow and supply to the heart muscle and improved the pumping action of the heart muscle
In this study researchers will compare the effectiveness of enalapril and losartan when given separately and together to patients with hypertrophic cardiomyopathy HCM
This study is designed to compare the ability of two drugs enalapril and losartan to improve symptoms and heart function of patients diagnosed with hypertrophic cardiomyopathy HCM
Researchers have decided to compare these drugs because each one has been used to treat patients with other diseases causing thickening of the heart muscle In these other conditions enalapril and losartan have improved symptoms decreased the thickness of heart muscle improved blood flow and supply to the heart muscle and improved the pumping action of the heart muscle
In this study researchers will compare the effectiveness of enalapril and losartan when given separately and together to patients with hypertrophic cardiomyopathy HCM
Detailed Description:
Hypertrophic cardiomyopathy HCM is a genetic cardiac disease characterized by left ventricular LV hypertrophy There is often associated LV diastolic dysfunction and myocardial ischemia The severity of the LV hypertrophy diastolic dysfunction and myocardial ischemia are important determinants of clinical outcomes Angiotensin II modulates cell growth and cardiac function There is also increasing evidence that the renin-angiotensin system RAS may be present in cardiac cells and the hypertrophic action of angiotensin II could therefore be mediated by circulating or locally produced hormone Animal and clinical studies have demonstrated that independent of their effects on systemic blood pressure ACE inhibition and angiotensin II receptor AT1 blockade can reduce cardiac hypertrophy improve LV diastolic function and myocardial ischemia AT1 blockade may be preferable to ACE inhibitors because by inhibiting angiotensin II from binding to its receptor the system can be turned off irrespective of the source of angiotensin II Also there may be fewer side effects due to lack of bradykinin This is a double-blind placebo-controlled study that examines the abilities of enalapril ACE inhibition and losartan AT1 blockade separately or in combination to cause regression of the cardiac hypertrophy and to improve LV function and myocardial perfusion in non-obstructive HCM
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 |
|---|---|---|---|
| 96-H-0144 | None | None | None |