Back to resultsEffect of LCZ696 on Urinary Microalbumin and Pulse Wave Velocity in Perimenopausal Patients With Hypertension
Primary Purpose
Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sacubitril/Valsartan
Valsartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring perimenopausal, hypertensive, Sacubitril/Valsartan, pulse wave velocity, urinary microalbuminuria
Eligibility Criteria
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;
Sites / Locations
- Department of Cardiology, Second Hospital of Lanzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sacubitril/Valsartan
Valsartan
Arm Description
receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan
receive once-daily treatment with 80-320 mg of Valsartan
Outcomes
Primary Outcome Measures
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
urinary microalbuminuria
Changes in this major indicators were detected before and after drug treatment in both groups
pulse wave velocity
Changes in this major indicators were detected before and after drug treatment in both groups
ventricular mass indexwere measured by cardiac ultrasound
Changes in this major indicators were detected before and after drug treatment in both groups
Secondary Outcome Measures
Adverse events
such as arrhythmology，dizzy， headache，edema，cough.Other incidents are even more serious
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04800081
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
June 9, 2021 (Anticipated)
Study Completion Date
July 9, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LanZhou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
perimenopausal, hypertensive, Sacubitril/Valsartan, pulse wave velocity, urinary microalbuminuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
264 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sacubitril/Valsartan
Arm Type
Experimental
Arm Description
receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan
Arm Title
Valsartan
Arm Type
Active Comparator
Arm Description
receive once-daily treatment with 80-320 mg of Valsartan
Intervention Type
Drug
Intervention Name(s)
Sacubitril/Valsartan
Other Intervention Name(s)
LCZ696
Intervention Description
Patients will be randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan.
Intervention Type
Drug
Intervention Name(s)
Valsartan
Other Intervention Name(s)
Diovan
Intervention Description
Patients will be randomized to receive once-daily treatment with 80-320 mg of Valsartan.
Primary Outcome Measure Information:
Title
Blood pressure，24 hour automatic blood pressure monitoring，home blood pressure monitoring，Office blood pressure
Description
Changes in this major indicators were detected before and after drug treatment in both groups
Time Frame
Evaluation at 12 weeks of treatment will be reported
Title
urinary microalbuminuria
Description
Changes in this major indicators were detected before and after drug treatment in both groups
Time Frame
Evaluation at 12 weeks of treatment will be reported
Title
pulse wave velocity
Description
Changes in this major indicators were detected before and after drug treatment in both groups
Time Frame
Evaluation at 12 weeks of treatment will be reported
Title
ventricular mass indexwere measured by cardiac ultrasound
Description
Changes in this major indicators were detected before and after drug treatment in both groups
Time Frame
Evaluation at 12 weeks of treatment will be reported
Secondary Outcome Measure Information:
Title
Adverse events
Description
such as arrhythmology，dizzy， headache，edema，cough.Other incidents are even more serious
Time Frame
During the drug intervention up to 30 days,60 days and 80days,it will bereported in the final.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Pei, MD
Phone
+86-0931-17318717573
Email
peiy19@lzu.edu.cn
Facility Information:
Facility Name
Department of Cardiology, Second Hospital of Lanzhou University
City
Lanzhou
State/Province
GuSu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Pei, MD
Phone
+86-0931-17318717573
Email
peiy19@lzu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Effect of LCZ696 on Urinary Microalbumin and Pulse Wave Velocity in Perimenopausal Patients With Hypertension
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