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

NCT ID: NCT04800081

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-09
• Study Completion Date: 2021-07-09

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sacubitril/Valsartan

receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan

Group Type: EXPERIMENTAL

Sacubitril/Valsartan

Intervention Type: DRUG

Patients will be randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan.

Valsartan

receive once-daily treatment with 80-320 mg of Valsartan

Group Type: ACTIVE_COMPARATOR

Valsartan

Intervention Type: DRUG

Patients will be randomized to receive once-daily treatment with 80-320 mg of Valsartan.

Interventions

Sacubitril/Valsartan

Patients will be randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan.

Intervention Type: DRUG

Valsartan

Patients will be randomized to receive once-daily treatment with 80-320 mg of Valsartan.

Intervention Type: DRUG

Other Intervention Names

LCZ696; Diovan

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;

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

LanZhou University

OTHER

Sponsor Role: lead

Responsible Party

Ying Pei

house physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Cardiology, Second Hospital of Lanzhou University

Lanzhou, GuSu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Pei, MD

Role: CONTACT

peiy19@lzu.edu.cn

+86-0931-17318717573

Facility Contacts

Ying Pei, MD

Role: primary

peiy19@lzu.edu.cn

+86-0931-17318717573

Other Identifiers

2020A-247

Identifier Type: -

Identifier Source: org_study_id