Myocardial Ischemia Clinical Trial
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
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).
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. ;
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