Clinical trial NCT04800081: Effect of LCZ696 on Urinary Microalbumin and Pulse Wave Velocity in Perimenopausal Patients With Hypertension
Official title: Effect of Sacubitril/Valsartan on Urinary Microalbumin and Pulse Wave Velocity in Perimenopausal Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: perimenopausal
hypertensive
Sacubitril/Valsartan
pulse wave velocity
urinary microalbuminuria
Lead sponsor: LanZhou University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 264
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.

1. To evaluate the effects of Sacubitril/Valsartan on urinary microalbumin and pulse wave velocity in perimenopausal hypertension patients.
2. 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 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)；
2. Female aged 45-55 years old and meeting the perimenopausal criteria in the STRAE+10;
3. No other complications, no treatment or ongoing antihypertensive therapy (SBP ≥140mmHg or Diastolic BP ≥90mmHg)；
4. Agree to participate in the study and sign the informed consent；

Exclusion Criteria:

1. Secondary hypertension；
2. History of angioedema；
3. Heart failure NYHA grade III or above (excluding grade III)；
4. 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);
5. Hyperkalemia (serum potassium ≥5.5mmol/L);
6. Moderate or above anemia (HGB≤90g/L);
7. Bilateral renal artery stenosis;
8. History of stroke;

Primary outcomes:
measure: Blood pressure，24 hour automatic blood pressure monitoring，home blood pressure monitoring，Office blood pressure
timeFrame: Evaluation at 12 weeks of treatment will be reported
measure: urinary microalbuminuria
timeFrame: Evaluation at 12 weeks of treatment will be reported
measure: pulse wave velocity
timeFrame: Evaluation at 12 weeks of treatment will be reported
measure: ventricular mass indexwere measured by cardiac ultrasound
timeFrame: Evaluation at 12 weeks of treatment will be reported
Secondary outcomes:
measure: Adverse events
timeFrame: During the drug intervention up to 30 days,60 days and 80days,it will bereported in the final.
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Department of Cardiology, Second Hospital of Lanzhou University
state: GuSu
Study officials:
References: