HypertensionNCT03680313
Cardio-ankle Vascular Index (CAVI) in Hypertension Patients After One Year of Treatment
An observational study of Hypertension, run by Hanoi Medical University.
Trial summary
This study aimed to evaluate the role of the cardio-ankle vascular index (CAVI) in evaluating arterial stiffness changes, the degree of atherosclerosis in patients with hypertension after 1 year of treatment and analysis the correlation between CAVI and cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Hypertension outpatient treatment
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 1 Jun 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The eligible patients were prospectively monitored to evaluate CAVI in hypertension treatment for every 3 months. All participants will be asked directly medical history, clinical examination and performed blood pressure measurement thoroughly. All clinical information will be retained in medical record.
Who may be able to join
- Patients have never been diagnosed with hypertension.
- Patients have been diagnosed with primary hypertension, but not take any treatment
Who cannot join
- Cases with non-primary hypertension or suffering from cardiovascular complications such as myocardial infarction, cerebral stroke, vascular disease, severe heart failure (EF<1) in the time of measurement.
About this study
This study aimed to evaluate the role of the cardio-ankle vascular index (CAVI) in evaluating arterial stiffness changes, the degree of atherosclerosis in patients with hypertension after 1 year of treatment and analysis the correlation between CAVI and cardiovascular risk factors.
- Conditions
- Hypertension
- Being tested
- Hypertension outpatient treatment
- Keywords
- Cardio-ankle vascular index (CAVI)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertension outpatient treatmentProcedure or surgery
Patients who have been diagnosed with primary hypertension and meet the conditions of the study will receive outpatient treatment
| Study group | Role | What they receive |
|---|---|---|
| Hypertension group | All adult patients (above 18 year of age) were recruited between May, 2016 and June 2017, at Duc Giang General Hospital. The inclusion criteria are as followed:
* Patients have never been diagnosed with hypertension.
* Has been diagnosed with primary hypertension, but not take any treatment. Receives: Procedure: Hypertension outpatient treatment | |
| Control group | A group of normal people with the similar age to hypertension group was recruited as control group at the same time |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAVI score in hypertension group after one year of treatment
CAVI score of patients who achieved their target blood pressure after one year of hypertension treatment
Measured: 1 year
Secondary outcomes (4)
Correlation between CAVI and smoking status
Evaluating correlation between CAVI score and smoking status in hypertension patients
Measured: 1 year
Correlation between CAVI and overweight status
Evaluating correlation between CAVI score and overweight status in hypertension patients
Measured: 1 year
Correlation between CAVI and diabetes status
Evaluating correlation between CAVI score and diabetes status in hypertension patients
Measured: 1 year
Correlation between CAVI and dislypidemia status
Evaluating correlation between CAVI score and dyslipidemia status in hypertension patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start1 May 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bui My Hanh, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680313
- Sponsor's protocol ID
- HMU16225
- Status last verified
- Sep 2018
- First submitted
- 18 Sep 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-ankle Vascular Index (CAVI) in Hypertension Patients After One Year of Treatment
- ClinicalTrials.gov ID
- NCT03680313
- Acronym / sponsor ID
- HMU16225
- Conditions
- Hypertension
- Keywords
- Cardio-ankle vascular index (CAVI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 21 Sep 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 aimed to evaluate the role of the cardio-ankle vascular index (CAVI) in evaluating arterial stiffness changes, the degree of atherosclerosis in patients with hypertension after 1 year of treatment and analysis the correlation between CAVI and cardiovascular risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertension group | – | Procedure: Hypertension outpatient treatmentAll adult patients (above 18 year of age) were recruited between May, 2016 and June 2017, at Duc Giang General Hospital. The inclusion criteria are as followed: * Patients have never been diagnosed with hypertension. * Has been diagnosed with primary hypertension, but not take any treatment. |
| Control group | – | –A group of normal people with the similar age to hypertension group was recruited as control group at the same time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible patients were prospectively monitored to evaluate CAVI in hypertension treatment for every 3 months. All participants will be asked directly medical history, clinical examination and performed blood pressure measurement thoroughly. All clinical information will be retained in medical record.
Key inclusion criteria (2 listed)
- Patients have never been diagnosed with hypertension.
- Patients have been diagnosed with primary hypertension, but not take any treatment
Key exclusion criteria (1 listed)
- Cases with non-primary hypertension or suffering from cardiovascular complications such as myocardial infarction, cerebral stroke, vascular disease, severe heart failure (EF<1) in the time of measurement.
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 |
|---|---|---|
| Hypertension outpatient treatmentPatients who have been diagnosed with primary hypertension and meet the conditions of the study will receive outpatient treatment | Procedure or surgery | Hypertension group |
Primary outcome
CAVI score in hypertension group after one year of treatment
Time frame: 1 year
CAVI score of patients who achieved their target blood pressure after one year of hypertension treatment
4 secondary outcomes
Correlation between CAVI and smoking status
Time frame: 1 year
Correlation between CAVI and overweight status
Time frame: 1 year
Correlation between CAVI and diabetes status
Time frame: 1 year
Correlation between CAVI and dislypidemia status
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Hypertension, run by Hanoi Medical 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 21 Sep 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CAVI score in hypertension group after one year of treatment (time frame: 1 year). 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 21 Sep 2018.