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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: Sacubitril/Valsartan; Drug: Valsartan

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.

• Study Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Pei, MD; Phone Number: +86-0931-17318717573; Email: peiy19@lzu.edu.cn

Study Locations

• China
  • GuSu
    • Lanzhou, GuSu, China
      • Recruiting
      • Department of Cardiology, Second Hospital of Lanzhou University
      • Contact: Ying Pei, MD; Phone Number: +86-0931-17318717573; Email: peiy19@lzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sacubitril/Valsartan; receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan	Drug: Sacubitril/Valsartan; Patients will be randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan.; Other Names: LCZ696
ACTIVE_COMPARATOR: Valsartan; receive once-daily treatment with 80-320 mg of Valsartan	Drug: Valsartan; Patients will be randomized to receive once-daily treatment with 80-320 mg of Valsartan.; Other Names: Diovan

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: LanZhou University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2020
• Primary Completion (ANTICIPATED): June 9, 2021
• Study Completion (ANTICIPATED): July 9, 2021

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (ACTUAL): March 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: pulse wave velocity; Sacubitril/Valsartan; hypertensive; perimenopausal; urinary microalbuminuria
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: 2020A-247

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No