Sacubitril/Valsartan Versus Amlodipine in Hypertension and Left Ventricular Hypertrophy.
NCT ID: NCT04929600
Last Updated: 2023-04-12
Study Results
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Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2021-11-28
2023-12-31
Brief Summary
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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.
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Detailed Description
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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 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.
7. 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.
8. 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.
9. Sample size: At least 60 eligible patients should be enrolled in each group, and a total of 120 patients should be enrolled 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.
11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental
One pill of sacubitril/valsartan (200mg tablet) + one pill of matching placebo of amlodipine daily. If possible, dosage titration should be conducted.
sacubitril/valsartan
Sacubitril/valsartan oral tablets (200mg) one pill a day + matching placebo of amlodipine one pill a day.
Comparator
One pill of amlodipine (5mg tablet) + one pill of matching placebo of sacubitril/valsartan daily. If possible, dosage titration should be conducted.
Amlodipine
Amlodipine oral tablets (5mg) one pill a day + matching placebo of sacubitril/valsartan one pill a day.
Interventions
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sacubitril/valsartan
Sacubitril/valsartan oral tablets (200mg) one pill a day + matching placebo of amlodipine one pill a day.
Amlodipine
Amlodipine oral tablets (5mg) one pill a day + matching placebo of sacubitril/valsartan one pill a day.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Ji-Guang Wang
Director of the Shanghai Institute of Hypertension
Locations
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Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Countries
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Facility Contacts
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Other Identifiers
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PARASTRAIN
Identifier Type: -
Identifier Source: org_study_id
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