Hypertension,EssentialNCT05513430
Pharmacological and Nonpharmacological Factors That Contribute Blood Pressure Control
An observational study of Hypertension,Essential, run by Maltepe University.
Trial summary
Study is an observational study among hypertensive patients Read more about this study
- Who is it for?
- Ages Up to 74 years
- Conditions the study is for
- Hypertension,Essential
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2014to 30 Nov 2014
- 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 Up to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: hypertensive patients
Who may be able to join
None listed.
Who cannot join
- -not willing to join the clinical trial
About this study
Study is an observational study among hypertensive patients
Read the detailed description
Objective: To investigate drug adherence and lifestyle behaviors affecting the blood pressure (BP) control among hypertensive patients that have uncontrolled and controlled BP.
- Conditions
- Hypertension,Essential
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| controlled hypertension | Controlled hypertension was defined as systolic blood pressure (SBP) ≤139 mmHg and/or diastolic blood pressure (DBP)≤89 mmHg for non-diabetic patients, and as SBP ≤139 mmHg and/or DBP ≤84 mmHg for diabetic patients, based on the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) guidelines. observational study | |
| uncontrolled hypertensive patients. | Individuals who had blood pressure levels above these values were defined as uncontrolled hypertensive patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
health related quality of life.
EQ-5D-3L turkish validation test
Measured: at the time of the beginning of the study
Age
years
Measured: at the time of the beginning of the study
Gender
Female/Male
Measured: at the time of the beginning of the study
BMI
(kg/m2)
Measured: at the time of the beginning of the study
Secondary outcomes (1)
complementary and alternative medicine use
subjective reports from patients (yes/no)
Measured: at the time of the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start16 Jun 2014
- Primary completion30 Nov 2014
- Study completion30 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies 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
- Cross-sectional
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Asst. Prof. Zeynep Gunes Ozunal, M.D., Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513430
- Sponsor's protocol ID
- 000001
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2017
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
PubMed 23817082Özünal, Z. G., Tahirbegolli, I. A., Baykal, M., Belen, A. T. E. Ş., Tahirbegolli, B., KILIÇ, Y., ... & Üresin, A. Y. (2019). The drug adherence and lifestyle factors that contribute to blood pressure control among hypertensive patients.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological and Nonpharmacological Factors That Contribute Blood Pressure Control
- ClinicalTrials.gov ID
- NCT05513430
- Acronym / sponsor ID
- 000001
- Conditions
- Hypertension,Essential
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 30 Nov 2014 (actual)
- First posted
- 24 Aug 2022 (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.
Study is an observational study among hypertensive patients
Detailed description
Objective: To investigate drug adherence and lifestyle behaviors affecting the blood pressure (BP) control among hypertensive patients that have uncontrolled and controlled BP.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| controlled hypertension | – | –Controlled hypertension was defined as systolic blood pressure (SBP) ≤139 mmHg and/or diastolic blood pressure (DBP)≤89 mmHg for non-diabetic patients, and as SBP ≤139 mmHg and/or DBP ≤84 mmHg for diabetic patients, based on the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) guidelines. observational study |
| uncontrolled hypertensive patients. | – | –Individuals who had blood pressure levels above these values were defined as uncontrolled hypertensive patients. |
Who may qualify
- Ages
- Up to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- hypertensive patients
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -not willing to join the clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
health related quality of life.
Time frame: at the time of the beginning of the study
EQ-5D-3L turkish validation test
Age
Time frame: at the time of the beginning of the study
years
Gender
Time frame: at the time of the beginning of the study
Female/Male
BMI
Time frame: at the time of the beginning of the study
(kg/m2)
1 secondary outcome
complementary and alternative medicine use
Time frame: at the time of the beginning of the study
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 24 Aug 2022.
- Background: PubMed 23817082Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
- Results publicationÖzünal, Z. G., Tahirbegolli, I. A., Baykal, M., Belen, A. T. E. Ş., Tahirbegolli, B., KILIÇ, Y., ... & Üresin, A. Y. (2019). The drug adherence and lifestyle factors that contribute to blood pressure control among hypertensive patients.
- Individual participant dataSharing planned: No
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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,Essential, run by Maltepe 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 0 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 24 Aug 2022. 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?
health related quality of life. (time frame: at the time of the beginning of the study). 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?
On the ClinicalTrials.gov record for NCT05513430, which also lists 2 linked publications.
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 24 Aug 2022.