Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | One pill of sacubitril/valsartan (200mg tablet) + one pill of matching placebo of amlodipine daily. If possible, dosage titration should be conducted. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sacubitril/valsartan | Drug | Sacubitril/valsartan oral tablets (200mg) one pill a day + matching placebo of amlodipine one pill a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in LVGLS after 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). | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LVGLS after 12 weeks | Change in left ventricular global longitudinal strain (LVGLS) after 12-week treatments. At baseline and 12-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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | 200025 | China |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
After screening and run-in period, eligible patients will be randomly assigned into ARNI group (sacubitril/valsartan 200-400mg QD) or amlodipine group (amlodipine 5-10mg QD).
Not provided
Not provided
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.
| Amlodipine | Drug | Amlodipine oral tablets (5mg) one pill a day + matching placebo of sacubitril/valsartan one pill a day. |
|
| Baseline and 12 weeks |
| Changes in LVMI after 24 weeks | At baseline and 24-week follow-up, all patients will undergo standard transthoracic echocardiography, Images of parasternal long axis view will be recorded to measure left ventricular end-diastole diameter (LVEDD), interventricular septal (IVS) and left ventricular posterior wall thickness (LVPW), and left ventricular mass will be calculated using the formula: 0.8*{1.04*[(LVEDD+IVS+LVPW)^3-LVEDD^3]}+0.6, and indexed by body surface area (BSA) as left ventricular mass index (LVMI). | Baseline and 24 weeks |
| Changes in LVMI after 12 weeks | At baseline and 12-week follow-up, all patients will undergo standard transthoracic echocardiography, Images of parasternal long axis view will be recorded to measure left ventricular end-diastole diameter (LVEDD), interventricular septal (IVS) and left ventricular posterior wall thickness (LVPW), and left ventricular mass will be calculated using the formula: 0.8*{1.04*[(LVEDD+IVS+LVPW)^3-LVEDD^3]}+0.6, and indexed by body surface area (BSA) as left ventricular mass index (LVMI). | Baseline and 12 weeks |
| Blood pressure after 24 weeks | Changes in clinic blood pressure, ambulatory blood pressureover 24 hours, daytime and nighttime after 24-week treatments. | Baseline and 24 weeks |
| Blood pressure after 12 weeks | Changes in clinic blood pressure, ambulatory blood pressureover 24 hours, daytime and nighttime after 12-week treatments. | Baseline and 12 weeks |
| D006984 |
| Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |