Effect of LCZ696 on Urinary Microalbumin and Pulse Wave Velocity in Perimenopausal Patients With Hypertension

Study Overview
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Brief Summary
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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. To evaluate the effects of Sacubitril/Valsartan on urinary microalbumin and pulse wave velocity in perimenopausal hypertension patients. To evaluate the clinical application of Sacubitril/Valsartan in the treatment of perimenopausal hypertension, so as to improve the blood pressure management ability and control rate of patients with such hypertension.

Detailed Description
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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.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.

Official Title
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Effect of Sacubitril/Valsartan on Urinary Microalbumin and Pulse Wave Velocity in Perimenopausal Patients With Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Sacubitril/Valsartan
* Drug: Valsartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with essential hypertension（SBP>140 and <180 mmHg, and/or DBP>90 and <110 mmHg)）were diagnosed according to the hypertension diagnostic criteria of the Chinese Guidelines for Hypertension (2018 Revised Edition)； Female aged 45-55 years old and meeting the perimenopausal criteria in the STRAE+10; No other complications, no treatment or ongoing antihypertensive therapy (SBP ≥140mmHg or Diastolic BP ≥90mmHg)； Agree to participate in the study and sign the informed consent； Exclusion Criteria: Secondary hypertension； History of angioedema； Heart failure NYHA grade III or above (excluding grade III)； Liver and kidney dysfunction (ALT or AST≥ three times the upper limit of normal value, that is, ALT≥120U/L,AST≥120U/L, creatinine clearance < 30ml/min); Hyperkalemia (serum potassium ≥5.5mmol/L); Moderate or above anemia (HGB≤90g/L); Bilateral renal artery stenosis; History of stroke;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sacubitril/Valsartan<br>receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan | Drug: Sacubitril/Valsartan<br>* Patients will be randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan.<br>* Other names: LCZ696;|
| Active Comparator: Valsartan<br>receive once-daily treatment with 80-320 mg of Valsartan | Drug: Valsartan<br>* Patients will be randomized to receive once-daily treatment with 80-320 mg of Valsartan.<br>* Other names: Diovan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perimenopausal, hypertensive, Sacubitril/Valsartan, pulse wave velocity, urinary microalbuminuria