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To explore the efficacy of Sacubitril/Valsartan in the treatment of perimenopausal hypertensive patients, as well as the difference between the antihypertensive efficacy and valsartan, the therapeutic effect of its exposure to different factors and the protection of target organs.To provide reference for the clinical treatment of perimenopausal hypertension patients with shakubactrivalsartan.
A total of 264 cases of perimenopausal patients with essential hypertension who were admitted to Department of Cardiology, Second Hospital of Lanzhou University,from January, 2020 to March,2021 will be enrolled and randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan or 80-320 mg of Valsartan.The general information, menstrual history, cardiac ultrasound, urinal-renal function, PWV, baseline blood pressure, post-medication blood pressure, whether to use antihypertensive drugs and the type of antihypertensive drugs of the patients were enrolled.After 12 weeks of drug intervention, left ventricular mass indexwere measured by cardiac ultrasound, PWV, urinary microalbinin, 24-hour ambulatory blood pressure monitoring, biochemical indicators will be collected.SPSS22.0 statistical software was used for statistical analysis of PWV, urinary microalbumin, blood pressure and other results by paired data t-test, and the chi-square test was used for non-count data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacubitril/Valsartan | Experimental | receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan |
|
| Valsartan | Active Comparator | receive once-daily treatment with 80-320 mg of Valsartan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacubitril/Valsartan | Drug | Patients will be randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure,24 hour automatic blood pressure monitoring,home blood pressure monitoring,Office blood pressure | Changes in this major indicators were detected before and after drug treatment in both groups | Evaluation at 12 weeks of treatment will be reported |
| urinary microalbuminuria | Changes in this major indicators were detected before and after drug treatment in both groups | Evaluation at 12 weeks of treatment will be reported |
| pulse wave velocity | Changes in this major indicators were detected before and after drug treatment in both groups | Evaluation at 12 weeks of treatment will be reported |
| ventricular mass indexwere measured by cardiac ultrasound | Changes in this major indicators were detected before and after drug treatment in both groups | Evaluation at 12 weeks of treatment will be reported |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | such as arrhythmology,dizzy, headache,edema,cough.Other incidents are even more serious | During the drug intervention up to 30 days,60 days and 80days,it will bereported in the final. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Pei, MD | Contact | +86-0931-17318717573 | peiy19@lzu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Second Hospital of Lanzhou University | Recruiting | Lanzhou | GuSu | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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A total of 264 cases of perimenopausal patients with essential hypertension who were admitted to Department of Cardiology, Second Hospital of Lanzhou University,from January, 2020 to March,2021 will be enrolled and randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan or 80-320 mg of Valsartan.
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| Valsartan | Drug | Patients will be randomized to receive once-daily treatment with 80-320 mg of Valsartan. |
|
|
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |