Amlodipine Versus Valsartan for Improvement of Diastolic Dysfunction Associated With Hypertension
Status:
Completed
Trial end date:
2020-01-06
Target enrollment:
Participant gender:
Summary
Hypertensive patients are at increased risk of developing LV hypertrophy and myocardial
fibrosis, which cause diastolic dysfunction. Because the activation of
rennin-angiotensin-aldosterone system (RAAS) has been shown to induce LV hypertrophy and
myocardial fibrosis, the RAAS may play a central role in the pathogenic process from
hypertension to diastolic HF. Inhibitors of RAAS have been considered as a treatment option
for these patients, and the angiotensin receptor blockers (ARB) have been of interest because
they antagonize the effects of angiotensin II more completely. However, the Irbesartan in
Heart Failure with Preserved Systolic Function (I-PRESERVE) trial reported that treatment
with irbesartan did not reduce the risk of death or hospitalization for cardiovascular causes
among 4,128 patients who had HF with a preserved LV ejection fraction. The degree of
improvement of diastolic dysfunction was associated with the extent of systolic blood
pressure reduction, whether a RAAS inhibitor or non-RAAS blood pressure lowering was used.
Amlodipine is a potent and well-tolerated calcium channel blocker, and seems to be
appropriate for achieving more aggressive systolic blood pressure target and improving
diastolic dysfunction in hypertensive patients, because amlodipine is clinically very useful
for controlling systolic blood pressure. Assessment of diastolic function by echocardiography
will be helpful to determine whether addition of amlodipine or an ARB to standard therapy is
more beneficial to hypertensive patients with diastolic dysfunction. The investigators
hypothesize that amlodipine added to standard therapy will be superior to valsartan in
improving diastolic dysfunction by lowering systolic blood pressure more effectively in
hypertensive patients, and try to examine this hypothesis in a prospective, open-label,
randomized comparison study using blinded echocardiographic evaluation for end point.