Sacubitril/Valsartan Versus Amlodipine in Hypertension and Left Ventricular Hypertrophy.
Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
1. Study name: Prospective Comparison of Angiotensin receptor neprilysin inhibitor (ARNI)
with Amlodipine on ventricular remodeling in hypertension and left ventricular
hypertrophy.
2. Medicine: sacubitril/valsartan (ARNI, 200mg tablet) and the matching placebo; amlodipine
(5mg tablet) and the matching placebo.
3. Rationale: according to the results of previous clinical studies, ARNI has obvious
advantages in improving cardiac remodeling and reducing blood pressure. However, there
is no evidence to demonstrate the efficacy of ARNI in reducing blood pressure and
improving ventricular remodeling in hypertension patients with left ventricular
hypertrophy (LVH) compared with calcium channel blockers.
4. Objective: to demonstrate the superior efficacy of ARNI on improvement of LVH and blood
pressure control compared with amlodipine in hypertension patients with LVH.
5. Study design: This study This is a 24-week prospective, randomized, active-controlled,
double-blind, multi-center study, with two equally sized treatment groups:
sacubitril/valsartan (200mg tablet); amlodipine (5mg tablet).
6. Study population: men or women aged over 18 years; Untreated patients or patients with
taking single antihypertensive drugs; Essential mild to moderate hypertension;
Echocardiographic diagnosis of LVH.
7. Randomization and treatment: Eligible patients will be randomly divided into 2 groups,
taking one pill of sacubitril/valsartan (200mg tablet) + one pill of matching placebo of
amlodipine daily, or one pill of amlodipine (5 mg/tablet) + one pill of matching placebo
of sacubitril/valsartan daily.
8. Follow up: after meeting the inclusion criteria, there will be 2-week placebo run-in.
Then patients will be randomly assigned into ARNI group and amlodipine group. There will
be 5 visiting points in the treatment period, which will be the 4th week, 8th week, 12th
week, 18th week and 24th week.
9. Sample size: 120 patients in total.
10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in April
2021, recruitment will start. Patients enrollment and follow-up will be performed
between June 2021 to June 2022.