临床试验/NCT04929600

NCT04929600招募中4 期

Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor (ARNI) With Amlodipine on Ventricular Remodeling in Hypertension and Left Ventricular Hypertrophy.

Shanghai Jiao Tong University School of Medicine1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2021年11月28日最近更新: 2023年4月12日

适应症

干预措施

试验速览

阶段: 4 期
状态: 招募中
发起方
入组人数: 120
试验地点: 1
主要终点: Change in LVGLS after 24 weeks

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Study name: Prospective Comparison of Angiotensin receptor neprilysin inhibitor (ARNI) with Amlodipine on ventricular remodeling in hypertension and left ventricular hypertrophy.
Medicine: sacubitril/valsartan (ARNI, 200mg tablet) and the matching placebo; amlodipine (5mg tablet) and the matching placebo.
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.
Objective: to demonstrate the superior efficacy of ARNI on improvement of LVH and blood pressure control compared with amlodipine in hypertension patients with LVH.
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).
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.
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.
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.
Sample size: 120 patients in total.
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.

详细描述

Study name: Prospective Comparison of Angiotensin receptor neprilysin inhibitor (ARNI) with Amlodipine on ventricular remodeling in hypertension and left ventricular hypertrophy.
Medicine: sacubitril/valsartan (ARNI, 200mg tablet) and the matching placebo; amlodipine (5mg tablet) and the matching placebo.
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.
Objective: to demonstrate the superior efficacy of ARNI on improvement of LVH and blood pressure control compared with amlodipine in hypertension patients with LVH.
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).
Study population: men or women aged over 18 years will be screened for hypertension and LVH. Eligible patients should be untreated patients or patients with taking single antihypertensive drugs with essential mild to moderate hypertension (clinic systolic blood pressure ≥ 140 and < 180mmHg), and echocardiographic diagnosis of LVH (LVMI: male≥115g/m2, female≥ 95g/m2). Patients should have abilities to understand the study requirements and provide informed consent.
Randomization and treatment: After screening period and run-in period by centers, 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. At the 12th week of treatment, if systolic blood pressure ≥ 120 mmHg or diastolic blood pressure ≥ 80 mmHg and no safety problems, dosage titration (sacubitril/valsartan 200mg QD to 400mg QD, amlodipine 5mg QD to 10mg QD) should be conducted.
Follow up: after meeting the inclusion criteria, there will be 2-week placebo run-in. Clinic blood pressure, ambulatory blood pressure, echocardiography, NT proBNP, myocardial fibrosis index, concomitant medication records and adverse event records will be collected at randomization/the end of run-in period. Then patients will be randomly assigned into ARNI group and amlodipine group. The treatment will be observed for 24 weeks. 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. Global longitudinal strain (GLS) was detected at randomization, the 12th week and 24th week.
Sample size: At least 60 eligible patients should be enrolled in each group, and a total of 120 patients should be enrolled in total.
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.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Patients in ARNI group will take sacubitril/valsartan + matching placebo of amlodipine; Patients in amlodipine group will take amlodipine + matching placebo of sacubitril/valsartan. Any markers that can identify placebo or active drugs will be removed.

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Aged ≥18;
•Essential mild to moderate hypertension (office systolic blood pressure (SBP) ≥ 140 and < 180mmHg in untreated patients or patients with taking single antihypertensive drugs (not including single-pill combination))；
•Echocardiographic diagnosis of LVH，LVMI: male≥115g/m2, female≥ 95g/m2;
•Ability to understand the study requirements and provide informed consent.

排除标准

•Hypersensitivity history to any study drug or similar drug (ARB, ACEI, neprilysin inhibitor；
•Severe renal insufficiency (eGFR < 30 mL/min/1.73m2);
•Hyperkalemia (serum potassium > 5mmol/L);
•Active liver disease or hepatic insufficiency (AST or ALT > 3 times upper limit of normal);
•History of malignancy over the past 5 years;
•Severe disease patients with life expectancy of < 1 year;
•Previous or current diagnosis of heart failure;
•Stroke or myocardial infarction within 6 months;
•Previous or current atrial fibrillation, frequent ventricular premature beats, supraventricular tachycardia;
•Patients who are receiving other study drugs or study medical devices;
•Pregnant or lactating women;
•Other circumstances that patients are not appropriate for the study upon the investigator's judgment.

研究组 & 干预措施

Experimental

One pill of sacubitril/valsartan (200mg tablet) + one pill of matching placebo of amlodipine daily. If possible, dosage titration should be conducted.

干预措施: sacubitril/valsartan (Drug)

Comparator

Active Comparator

One pill of amlodipine (5mg tablet) + one pill of matching placebo of sacubitril/valsartan daily. If possible, dosage titration should be conducted.

干预措施: Amlodipine (Drug)

结局指标

主要结局

Change in LVGLS after 24 weeks

时间窗: Baseline and 24 weeks

Change in left ventricular global longitudinal strain (LVGLS) after 24-week treatments. At baseline and 24-week follow-up, all patients will undergo standard transthoracic echocardiography performed in the sinus rhythm using the Vivid E9 and E95 Echo-system (General Electric Medical Health, Milwaukee, Wisconsin, USA) equipped with a M5S transducer. LVGLS will be obtained from two-, three-, and four-chamber apical views, and LVGLS analysis will be performed using an offline software (EchoPac, Version 113; General Electric Medical Health).

次要结局

Change in LVGLS after 12 weeks(Baseline and 12 weeks)
Changes in LVMI after 24 weeks(Baseline and 24 weeks)
Changes in LVMI after 12 weeks(Baseline and 12 weeks)
Blood pressure after 24 weeks(Baseline and 24 weeks)
Blood pressure after 12 weeks(Baseline and 12 weeks)

研究者

发起方

Shanghai Jiao Tong University School of Medicine

申办方类型

Other

责任方

Principal Investigator

主要研究者

Ji-Guang Wang

Director of the Shanghai Institute of Hypertension

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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