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

NCT04800081 | Unknown

• 1 other identifier: 2020A-247
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Keywords

perimenopausal; hypertensive; Sacubitril/Valsartan; pulse wave velocity; urinary microalbuminuria

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Adverse events

  During the drug intervention up to 30 days,60 days and 80days,it will bereported in the final.

Study Arms (2)

Sacubitril/Valsartan

EXPERIMENTAL

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

Drug: Sacubitril/Valsartan

Valsartan

ACTIVE COMPARATOR

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

Drug: Valsartan

Interventions

Sacubitril/Valsartan DRUG

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

Also known as: LCZ696

Sacubitril/Valsartan

Valsartan DRUG

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

Also known as: Diovan

Valsartan

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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；

You may not qualify if:

• 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;

Sponsors & Collaborators

• LanZhou University: lead

Study Sites (1)

Department of Cardiology, Second Hospital of Lanzhou University

Lanzhou, GuSu, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

sacubitril and valsartan sodium hydrate drug combination; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Central Study Contacts

Ying Pei, MD

CONTACT

+86-0931-17318717573; peiy19@lzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: house physician

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 16, 2021
• Study Start: July 9, 2020
• Primary Completion: June 9, 2021
• Study Completion: July 9, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

CN (1)