HypertensionNCT01442116
Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension
A study testing stress echocardiography in people with Hypertension and Left Ventricular Hypertrophy, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The study hypothesis is stress-related regional tissue dynamics is related to left ventricular outflow tract blood flow. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Left Ventricular Hypertrophy
- What is being tested?
- stress echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2009to Dec 2009
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertension
Who cannot join
- History of Myocardial Infarction
- Diabetes Mellitus
- Renal Failure
- Orthopedic problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mustafa Kemal University School of Medicine, Department of Cardiology
Antioch, Antioch, 31100
About this study
The study hypothesis is stress-related regional tissue dynamics is related to left ventricular outflow tract blood flow.
- Conditions
- Hypertension, Left Ventricular Hypertrophy
- Being tested
- stress echocardiography
- 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.
stress echocardiographyProcedure or surgery
safety and efficacy of stress echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Hypertensives | Experimental | Not described Receives: Procedure: stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of LVOT velocity before and after exercise by echocardiography
Measured: 1 day (before and after exercise stress)
measurement of TDI S wave before and after exercise by echocardiography
Measured: 1 day (before and after exercise)
Secondary outcomes (1)
myocardial regional functions measured by tissue Doppler imagination
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2009
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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagehan Kucukler, Mustafa Kemal University
- Investigators
- Fatih Yalcin, MD, Study director, Mustafa Kemal University: Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442116
- Sponsor's protocol ID
- HT60
- Status last verified
- Sep 2011
- First submitted
- 15 Sep 2011
- Last updated
- 29 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension
- ClinicalTrials.gov ID
- NCT01442116
- Acronym / sponsor ID
- HT60
- Conditions
- Hypertension, Left Ventricular Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Sep 2011 (estimated)
- 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.
The study hypothesis is stress-related regional tissue dynamics is related to left ventricular outflow tract blood flow.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensives | Experimental | Procedure: stress echocardiography |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Essential hypertension
Key exclusion criteria (4 listed)
- History of Myocardial Infarction
- Diabetes Mellitus
- Renal Failure
- Orthopedic problems
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 |
|---|---|---|
| stress echocardiographysafety and efficacy of stress echocardiography | Procedure or surgery | Hypertensives |
Primary outcome
measurement of LVOT velocity before and after exercise by echocardiography
Time frame: 1 day (before and after exercise stress)
measurement of TDI S wave before and after exercise by echocardiography
Time frame: 1 day (before and after exercise)
1 secondary outcome
myocardial regional functions measured by tissue Doppler imagination
Time frame: 1 day
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 29 Sep 2011.
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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.
Fatih Yalcin, MD study director
Mustafa Kemal University: Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress echocardiography in people with Hypertension and Left Ventricular Hypertrophy, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 29 Sep 2011. 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 Turkey (Türkiye). 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?
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?
measurement of LVOT velocity before and after exercise by echocardiography (time frame: 1 day (before and after exercise stress)). The study lists 2 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 29 Sep 2011.