HypertensionNCT03432468
Effect of Fully Blocking Type 1 Angiotensin Receptor on Target Organ Damage of Postmenopausal Hypertensive Women
A study testing Valsartan 1 and Valsartan 80 mg in people with Hypertension, run by LanZhou University.
Trial summary
This study compared the improvements of blood pressure levels, left ventricular hypertrophy, left ventricular diastolic function, vascular function and cognitive function between postmenopausal hypertensive women and age-matched hypertensive male patients through the evaluation of the effects of fully blocked AT1… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Valsartan 1 and Valsartan 80 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 1 Aug 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hypertension
- Women are all postmenopausal
- Must provide written informed consent
Who cannot join
- Secondary hypertension
- Coronary disease
- Heart failure
- Arterial fibrillation
- Previous myocardial infarction
- Previous stroke
Show all 13Show fewer
- Malignant disease
- Kidney failure
- Liver failure
- Neoplastic disease
- Severe neurological diseases
- Severe metabolic or organic decompensation
- Refuse to sign the informed consent form
About this study
Official title: Effect of Fully Blocking Type 1 Angiotensin Receptor on Blood Pressure, Cardiac Structure, Cardiac Function and Cognitive Function in Postmenopausal Hypertensive Women
This study compared the improvements of blood pressure levels, left ventricular hypertrophy, left ventricular diastolic function, vascular function and cognitive function between postmenopausal hypertensive women and age-matched hypertensive male patients through the evaluation of the effects of fully blocked AT1 receptor by valsartan. Additionally, the differences of the above indexes between the patients who were fully blocked AT1 receptor by valsartan and the patients who were treated with a single dose of valsartan treatment were assessed, so as to provide theory basis for clinical treatment of postmenopausal hypertensive women.
- Conditions
- Hypertension
- Being tested
- Valsartan 1, Valsartan 80 mg
- Keywords
- Hypertension, Left Ventricular Hypertrophy, Women
- Medical subject headings
- Hypertension, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan 1Drug
the high dose of valsartan
Valsartan 80 mgDrug
a single dose of valsartan
| Study group | Role | What they receive |
|---|---|---|
| postmenopausal hypertensive women | Active comparator | Not described Receives: Drug: Valsartan 1; Drug: Valsartan 80 mg |
| age-matched hypertensive male patients | Placebo comparator | Not described Receives: Drug: Valsartan 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative indexes of myocardial remodeling
Cardiac structure (left ventricular mass index in grams for square meter) measurement.
Measured: Change from Baseline left ventricular mass index at 6 months.
Relative indexes of myocardial remodeling
Cardiac structure (left ventricular mass index in grams for square meter) measurement.
Measured: Change from Baseline left ventricular mass index at 12 months.
Ambulatory blood pressure monitoring
Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.
Measured: Change from Baseline ABPM at 6 months.
Ambulatory blood pressure monitoring
Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.
Measured: Change from Baseline ABPM at 12 months.
Sexual hormones
Blood samples used to analyze the levels of sexual hormones were collected between morning 8:00 and 9:00 after an overnight fast. The sexual hormones which include prolactin (PRL) and progesterone (P) units on nanogram per millilitre, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) units on millionInternationalUnits per millilitre, testosterone (T) in nanogram per deciliter, estradiol (E2) in picogram per millilitre.
Measured: Baseline sexual hormones.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Apr 2018 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (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
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Yu, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432468
- Sponsor's protocol ID
- LanZhouU
- Status last verified
- Jan 2018
- First submitted
- 19 Jan 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fully Blocking Type 1 Angiotensin Receptor on Blood Pressure, Cardiac Structure, Cardiac Function and Cognitive Function in Postmenopausal Hypertensive Women
- ClinicalTrials.gov ID
- NCT03432468
- Acronym / sponsor ID
- LanZhouU
- Conditions
- Hypertension
- Keywords
- Hypertension, Left Ventricular Hypertrophy, Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 14 Feb 2018 (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.
This study compared the improvements of blood pressure levels, left ventricular hypertrophy, left ventricular diastolic function, vascular function and cognitive function between postmenopausal hypertensive women and age-matched hypertensive male patients through the evaluation of the effects of fully blocked AT1 receptor by valsartan. Additionally, the differences of the above indexes between the patients who were fully blocked AT1 receptor by valsartan and the patients who were treated with a single dose of valsartan treatment were assessed, so as to provide theory basis for clinical treatment of postmenopausal hypertensive women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postmenopausal hypertensive women | Active comparator | Drug: Valsartan 1, Drug: Valsartan 80 mg |
| age-matched hypertensive male patients | Placebo comparator | Drug: Valsartan 1 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of hypertension
- Women are all postmenopausal
- Must provide written informed consent
Key exclusion criteria (13 listed)
- Secondary hypertension
- Coronary disease
- Heart failure
- Arterial fibrillation
- Previous myocardial infarction
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 |
|---|---|---|
| Valsartan 1the high dose of valsartan | Drug | age-matched hypertensive male patients, postmenopausal hypertensive women |
| Valsartan 80 mga single dose of valsartan | Drug | postmenopausal hypertensive women |
Primary outcome
Relative indexes of myocardial remodeling
Time frame: Change from Baseline left ventricular mass index at 6 months.
Cardiac structure (left ventricular mass index in grams for square meter) measurement.
Relative indexes of myocardial remodeling
Time frame: Change from Baseline left ventricular mass index at 12 months.
Cardiac structure (left ventricular mass index in grams for square meter) measurement.
Ambulatory blood pressure monitoring
Time frame: Change from Baseline ABPM at 6 months.
Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.
Ambulatory blood pressure monitoring
Time frame: Change from Baseline ABPM at 12 months.
Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.
Sexual hormones
Time frame: Baseline sexual hormones.
Blood samples used to analyze the levels of sexual hormones were collected between morning 8:00 and 9:00 after an overnight fast. The sexual hormones which include prolactin (PRL) and progesterone (P) units on nanogram per millilitre, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) units on millionInternationalUnits per millilitre, testosterone (T) in nanogram per deciliter, estradiol (E2) in picogram per millilitre.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Valsartan 1 and Valsartan 80 mg in people with Hypertension, run by LanZhou University.
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 3 inclusion and 13 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative indexes of myocardial remodeling (time frame: Change from Baseline left ventricular mass index at 6 months.). The study lists 5 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 13 Mar 2018.