HypertensionNCT04800081
Effect of LCZ696 on Urinary Microalbumin and Pulse Wave Velocity in Perimenopausal Patients With Hypertension
A study testing Sacubitril/Valsartan and Valsartan in people with Hypertension, run by LanZhou University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Sacubitril/Valsartan and Valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2020to 9 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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；
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, Second Hospital of Lanzhou University
Lanzhou, GuSu
Ying Pei, MD, +86-0931-17318717573, peiy19@lzu.edu.cn
About this study
Official title: 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.
- 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.
Read the 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
- Being tested
- Sacubitril/Valsartan, Valsartan
- Keywords
- perimenopausal, hypertensive, Sacubitril/Valsartan, pulse wave velocity, urinary microalbuminuria
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril/ValsartanDrug
Also called LCZ696
Patients will be randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan.
ValsartanDrug
Also called Diovan
Patients will be randomized to receive once-daily treatment with 80-320 mg of Valsartan.
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril/Valsartan | Experimental | receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan Receives: Drug: Sacubitril/Valsartan |
| Valsartan | Active comparator | receive once-daily treatment with 80-320 mg of Valsartan Receives: Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Evaluation at 12 weeks of treatment will be reported
Secondary outcomes (1)
Adverse events
such as arrhythmology，dizzy， headache，edema，cough.Other incidents are even more serious
Measured: During the drug intervention up to 30 days,60 days and 80days,it will bereported in the final.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start9 Jul 2020
- Primary completion9 Jun 2021 (estimated)
- Study completion9 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Pei, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800081
- Sponsor's protocol ID
- 2020A-247
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sacubitril/Valsartan on Urinary Microalbumin and Pulse Wave Velocity in Perimenopausal Patients With Hypertension
- ClinicalTrials.gov ID
- NCT04800081
- Acronym / sponsor ID
- 2020A-247
- Conditions
- Hypertension
- Keywords
- perimenopausal, hypertensive, Sacubitril/Valsartan, pulse wave velocity, urinary microalbuminuria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 9 Jun 2021 (estimated)
- Study completion
- 9 Jul 2021 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/Valsartan | Experimental | Drug: Sacubitril/Valsartanreceive once-daily treatment with 100-400 mg of Sacubitril/Valsartan |
| Valsartan | Active comparator | Drug: Valsartanreceive once-daily treatment with 80-320 mg of Valsartan |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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；
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril/ValsartanAlso: LCZ696Patients will be randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan. | Drug | Sacubitril/Valsartan |
| ValsartanAlso: DiovanPatients will be randomized to receive once-daily treatment with 80-320 mg of Valsartan. | Drug | Valsartan |
Primary outcome
Blood pressure，24 hour automatic blood pressure monitoring，home blood pressure monitoring，Office blood pressure
Time frame: Evaluation at 12 weeks of treatment will be reported
Changes in this major indicators were detected before and after drug treatment in both groups
urinary microalbuminuria
Time frame: Evaluation at 12 weeks of treatment will be reported
Changes in this major indicators were detected before and after drug treatment in both groups
pulse wave velocity
Time frame: Evaluation at 12 weeks of treatment will be reported
Changes in this major indicators were detected before and after drug treatment in both groups
ventricular mass indexwere measured by cardiac ultrasound
Time frame: Evaluation at 12 weeks of treatment will be reported
Changes in this major indicators were detected before and after drug treatment in both groups
1 secondary outcome
Adverse events
Time frame: During the drug intervention up to 30 days,60 days and 80days,it will bereported in the final.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacubitril/Valsartan and Valsartan in people with Hypertension, run by LanZhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Pei, MD (+86-0931-17318717573, peiy19@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure，24 hour automatic blood pressure monitoring，home blood pressure monitoring，Office blood pressure (time frame: Evaluation at 12 weeks of treatment will be reported). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.