HypertensionNCT06635616
Hypertension Management in Terms of Routine Agents
An observational study of Hypertension and Emergency Medicine, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
Trial summary
known hypertensive patients admitted to emergency department with increased blood pressure will be evaluated in terms of antihypertensive agents given at hospital, degree of blood pressure decrease, hospital stay and laboratory and imaging tests ordered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Emergency Medicine
- Type of treatment
- Pill or oral medicine
- How many people
- 350 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Nov 2025
- How long will I take part?
- 30 Days
- 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: patients with known hypertension admitted to emergency department with elevated blood pressure
Who may be able to join
- Patients aged 18 and older.
- Blood pressure measured at ≥140/80.
- Diagnosis of essential hypertension.
Who cannot join
- Pregnant patients.
- Individuals without a prior diagnosis of hypertension.
- Patients with end-organ damage (hypertensive emergency).
- Patients whose routine antihypertensive agents are unavailable.
- Patients who leave the clinic without permission, making follow-up data inaccessible.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Etlik City Hospital
Ankara, 06170
Gulsen AKCAY, ass. prof., +905052874949, gulakcay@yahoo.com.tr
Ilker SIRIN, Specialist, +905414684309, sirinilkerr@gmail.com
Etimesgut Military Hospital
Ankara, 06790
Elif HAMZACEIOGLU KAYISOGLU, Specialist, +905453300679, turkuaz-61@windowslive.com
About this study
Official title: Emergency Department Hypertension Management: Effects of Routine Oral Antihypertensive Agents on Emergency Management of Hypertension
known hypertensive patients admitted to emergency department with increased blood pressure will be evaluated in terms of antihypertensive agents given at hospital, degree of blood pressure decrease, hospital stay and laboratory and imaging tests ordered. The impact of routine oral antihypertensive agents used by the patients on these parameter will be assessed.
Read the detailed description
Hypertensive patients account for approximately 1-25% of annual emergency department visits . While this figure varies by region, hypertensive patients are among the groups that contribute significantly to emergency department crowding and workload . Hypertensive emergencies constitute about 0.3-0.9% of all patients, and this number is rapidly increasing each year .
The 2017 AHA hypertension guidelines emphasize that severe elevations in blood pressure (hypertensive crisis and hypertensive urgency) do not require emergency department visits or referrals unless there is end-organ damage . It is noted that treatment in these patients typically involves dose adjustment or a change in medication .
The 2023 ESC hypertension guidelines recommend that in patients presenting to the emergency department with a hypertensive crisis, blood pressure should be gradually lowered with oral agents over a 24-48 hour period. These patients do not usually require hospital admission but can be monitored in an outpatient setting for clinical evaluation. It is noted that their blood pressure may remain elevated upon discharge from the emergency department, and follow-up in a clinic is necessary for reevaluation of chronic therapy .
Some studies have indicated that both oral and intravenous treatments are preferred for patients presenting with hypertensive crises, highlighting that the approach can vary from physician to physician .
When evaluating literature reviews, published guidelines, and conducted studies, it is observed that there are differences between European and American approaches in defining and treating hypertensive crisis, as well as variability in physician management of these patients .
In our study, we plan to evaluate the effect of emergency department treatment on lowering blood pressure in known hypertensive patients (≥140/80) without end-organ damage. Additionally, we aim to assess the impact of the antihypertensive agents that patients routinely use on their length of stay in the emergency department, as well as the frequency and effectiveness of the medications used, and the target blood pressure values achieved post-treatment according to guidelines.
- Conditions
- Hypertension, Emergency Medicine
- Keywords
- hypertension, emergency medicine, oral antihypertensive agents
- Medical subject headings
- 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 |
|---|---|---|
| diuretics | patients prescribed diuretics for oral treatment admitted to emergency service with elevated blood pressure | |
| Beta Blockers | patients prescribed Beta Blockers for oral treatment admitted to emergency service with elevated blood pressure | |
| Calcium Channel Blockers | patients prescribed Calcium Channel Blockers for oral treatment admitted to emergency service with elevated blood pressure | |
| ACE (angiotensin converting enzyme) Inhibitors | patients prescribed ACE (angiotensin converting enzyme) Inhibitors for oral treatment admitted to emergency service with elevated blood pressure | |
| ARB( angiotensin receptor blockers) | patients prescribed ARB( angiotensin receptor blockers) for oral treatment admitted to emergency service with elevated blood pressure | |
| combination | patients prescribed combination agents for oral treatment admitted to emergency service with elevated blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
routine use of oral antihypertensive agents and its effects on emergency service care
emergency service blood pressure target achievement duration changes depending on routine oral antihypertensive agent prescribed
Measured: from enrollment to the end of follow up duration of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Etimesgut Military Hospital
- Responsible party
- Sponsor
- Investigators
- Elif HAMZACEBIOGLU KAYISOGLU, Specialist, Study director, Etimesgut Military HospitalGulsen AKCAY, Ass. Prof., Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635616
- Sponsor's protocol ID
- hypertension
- Status last verified
- Sep 2024
- First submitted
- 8 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salvetti M, Paini A, Colonetti E, Tarozzi L, Bertacchini F, Aggiusti C, Stassaldi D, Rosei CA, Rosei EA, Muiesan ML. Hypertensive emergencies and urgencies: a single-centre experience in Northern Italy 2008-2015. J Hypertens. 2020 Jan;38(1):52-58. doi: 10.1097/HJH.0000000000002213.
PubMed 31415308Nowicki J, Silka W, Zalustowicz A, Rajzer M, Olszanecka A. Uncontrolled hypertension and hypertensive urgency: One-year single-center emergency department experience. Kardiol Pol. 2024;82(4):407-415. doi: 10.33963/v.phj.100025. Epub 2024 Apr 12.
PubMed 38606743Astarita A, Covella M, Vallelonga F, Cesareo M, Totaro S, Ventre L, Apra F, Veglio F, Milan A. Hypertensive emergencies and urgencies in emergency departments: a systematic review and meta-analysis. J Hypertens. 2020 Jul;38(7):1203-1210. doi: 10.1097/HJH.0000000000002372.
PubMed 32510905
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Hypertension Management: Effects of Routine Oral Antihypertensive Agents on Emergency Management of Hypertension
- ClinicalTrials.gov ID
- NCT06635616
- Acronym / sponsor ID
- hypertension
- Conditions
- Hypertension, Emergency Medicine
- Keywords
- hypertension, emergency medicine, oral antihypertensive agents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Etimesgut Military Hospital
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 10 Oct 2024 (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.
known hypertensive patients admitted to emergency department with increased blood pressure will be evaluated in terms of antihypertensive agents given at hospital, degree of blood pressure decrease, hospital stay and laboratory and imaging tests ordered. The impact of routine oral antihypertensive agents used by the patients on these parameter will be assessed.
Detailed description
Hypertensive patients account for approximately 1-25% of annual emergency department visits . While this figure varies by region, hypertensive patients are among the groups that contribute significantly to emergency department crowding and workload . Hypertensive emergencies constitute about 0.3-0.9% of all patients, and this number is rapidly increasing each year .
The 2017 AHA hypertension guidelines emphasize that severe elevations in blood pressure (hypertensive crisis and hypertensive urgency) do not require emergency department visits or referrals unless there is end-organ damage . It is noted that treatment in these patients typically involves dose adjustment or a change in medication .
The 2023 ESC hypertension guidelines recommend that in patients presenting to the emergency department with a hypertensive crisis, blood pressure should be gradually lowered with oral agents over a 24-48 hour period. These patients do not usually require hospital admission but can be monitored in an outpatient setting for clinical evaluation. It is noted that their blood pressure may remain elevated upon discharge from the emergency department, and follow-up in a clinic is necessary for reevaluation of chronic therapy .
Some studies have indicated that both oral and intravenous treatments are preferred for patients presenting with hypertensive crises, highlighting that the approach can vary from physician to physician .
When evaluating literature reviews, published guidelines, and conducted studies, it is observed that there are differences between European and American approaches in defining and treating hypertensive crisis, as well as variability in physician management of these patients .
In our study, we plan to evaluate the effect of emergency department treatment on lowering blood pressure in known hypertensive patients (≥140/80) without end-organ damage. Additionally, we aim to assess the impact of the antihypertensive agents that patients routinely use on their length of stay in the emergency department, as well as the frequency and effectiveness of the medications used, and the target blood pressure values achieved post-treatment according to guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| diuretics | – | –patients prescribed diuretics for oral treatment admitted to emergency service with elevated blood pressure |
| Beta Blockers | – | –patients prescribed Beta Blockers for oral treatment admitted to emergency service with elevated blood pressure |
| Calcium Channel Blockers | – | –patients prescribed Calcium Channel Blockers for oral treatment admitted to emergency service with elevated blood pressure |
| ACE (angiotensin converting enzyme) Inhibitors | – | –patients prescribed ACE (angiotensin converting enzyme) Inhibitors for oral treatment admitted to emergency service with elevated blood pressure |
| ARB( angiotensin receptor blockers) | – | –patients prescribed ARB( angiotensin receptor blockers) for oral treatment admitted to emergency service with elevated blood pressure |
| combination | – | –patients prescribed combination agents for oral treatment admitted to emergency service with elevated blood pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with known hypertension admitted to emergency department with elevated blood pressure
Key inclusion criteria (3 listed)
- Patients aged 18 and older.
- Blood pressure measured at ≥140/80.
- Diagnosis of essential hypertension.
Key exclusion criteria (5 listed)
- Pregnant patients.
- Individuals without a prior diagnosis of hypertension.
- Patients with end-organ damage (hypertensive emergency).
- Patients whose routine antihypertensive agents are unavailable.
- Patients who leave the clinic without permission, making follow-up data inaccessible.
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
routine use of oral antihypertensive agents and its effects on emergency service care
Time frame: from enrollment to the end of follow up duration of 7 days
emergency service blood pressure target achievement duration changes depending on routine oral antihypertensive agent prescribed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Background: PubMed 31415308Salvetti M, Paini A, Colonetti E, Tarozzi L, Bertacchini F, Aggiusti C, Stassaldi D, Rosei CA, Rosei EA, Muiesan ML. Hypertensive emergencies and urgencies: a single-centre experience in Northern Italy 2008-2015. J Hypertens. 2020 Jan;38(1):52-58. doi: 10.1097/HJH.0000000000002213.
- Background: PubMed 38606743Nowicki J, Silka W, Zalustowicz A, Rajzer M, Olszanecka A. Uncontrolled hypertension and hypertensive urgency: One-year single-center emergency department experience. Kardiol Pol. 2024;82(4):407-415. doi: 10.33963/v.phj.100025. Epub 2024 Apr 12.
- Background: PubMed 32510905Astarita A, Covella M, Vallelonga F, Cesareo M, Totaro S, Ventre L, Apra F, Veglio F, Milan A. Hypertensive emergencies and urgencies in emergency departments: a systematic review and meta-analysis. J Hypertens. 2020 Jul;38(7):1203-1210. doi: 10.1097/HJH.0000000000002372.
- 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.
Elif HAMZACEBIOGLU KAYISOGLU, Specialist study director
Etimesgut Military Hospital
Gulsen AKCAY, Ass. Prof. principal investigator
Ankara Etlik City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Emergency Medicine, run by Saglik Bilimleri Universitesi at 2 sites 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 3 inclusion and 5 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 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gulsen AKCAY, Ass. Prof. (+905052874949, gulakcay@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
routine use of oral antihypertensive agents and its effects on emergency service care (time frame: from enrollment to the end of follow up duration of 7 days). 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 NCT06635616, which also lists 3 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 10 Oct 2024.