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Sacubitril/Valsartan Versus Amlodipine in Hypertension and Left Ventricular Hypertrophy.

NCT04929600 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-04-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

sacubitril/valsartan

Sacubitril/valsartan oral tablets (200mg) one pill a day + matching placebo of amlodipine one pill a day.

DRUG

Amlodipine

Amlodipine oral tablets (5mg) one pill a day + matching placebo of sacubitril/valsartan one pill a day.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-28
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04929600 on ClinicalTrials.gov