Hypertensive UrgencyNCT06635603
HYPERTENSIVE CRISIS AND ATMOSPHERIC PRESSURE RELATIONSHIP
An observational study of Hypertensive Urgency and Weather, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
relationship between the onset times of symptoms and the regions of patients presenting to the emergency department with hypertensive crisis (systolic ≥180 and/or diastolic ≥110 mmHg) and the fluctuations in atmospheric pressure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertensive Urgency, Weather
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 15 Sep 2025
- How long will I take part?
- 7 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 admitted to emergency department with hypertensive urgency ( systolic ≥180 and/or diastolic ≥110 mmHg )
Who may be able to join
- Age 18 and above
- Hypertensive crisis (systolic ≥180 and/or diastolic ≥110 mmHg)
Who cannot join
- Patients presenting with hypertensive emergency (those with end-organ damage)
- Patients who have traveled to another city or district within the last 4 days
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara, 06170
Gulsen AKCAY, Associate Professor, +905052874949, gulakcay@yahoo.com.tr
Elif HAMZACEBIOGLU KAYISOGLU, Specialist, +905453300679, turkuaz-61@windowslive.com
About this study
Official title: HYPERTENSIVE CRISIS AND ATMOSPHERIC PRESSURE RELATIONSHIP: A PROSPECTIVE STUDY
relationship between the onset times of symptoms and the regions of patients presenting to the emergency department with hypertensive crisis (systolic ≥180 and/or diastolic ≥110 mmHg) and the fluctuations in atmospheric pressure
Read the detailed description
Hypertensive emergency is defined as grade 3 hypertension (systolic ≥180 and/or diastolic ≥110 mmHg) that causes end-organ damage, requiring urgent intervention and intensive care admission . Hypertensive crisis is described as severe hypertension not associated with end-organ damage. Some sources define hypertensive crisis as hypertension of grade 3 or higher, while others refer to it as severe hypertension without specifying a threshold .
Literature reviews, published guidelines, and studies indicate that the definitions and treatment approaches for hypertensive crisis differ between Europe and America, with variations in management from one physician to another . Seasonal blood pressure fluctuations are influenced by external temperature, indoor temperature, humidity, atmospheric pressure, and wind . Notably, during periods of low atmospheric pressure, blood pressure measurements show statistically significant increases compared to other days . Consequently, the frequency of life-threatening conditions associated with hypertension, such as intracranial hemorrhage and abdominal aortic aneurysm rupture, has been observed to increase on days when atmospheric pressure changes .
In our study, we aim to investigate the relationship between the onset times of symptoms and the regions of patients presenting to the emergency department with hypertensive crisis (systolic ≥180 and/or diastolic ≥110 mmHg) and the fluctuations in atmospheric pressure
- Conditions
- Hypertensive Urgency, Weather
- Keywords
- atmospheric pressure, hypertension, hypertensive urgency
- Medical subject headings
- Hypertensive Crisis, 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 |
|---|---|---|
| hypertension | patients admitted to emergency department with grade 3 (systolic ≥180 and/or diastolic ≥110 mmHg) blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertensive Crisis
Patients' blood pressure values evaluation in terms of atmospheric pressure and weather conditions
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 start15 Sep 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 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 Hypertensive UrgencyStudies 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
- 7 Days
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Etimesgut Military Hospital
- Responsible party
- Sponsor
- Investigators
- Gulsen AKCAY, ass. prof., Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635603
- Sponsor's protocol ID
- Hypertension, ATM pressure
- Status last verified
- Oct 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 31415308Jehn M, Appel LJ, Sacks FM, Miller ER 3rd; DASH Collaborative Research Group. The effect of ambient temperature and barometric pressure on ambulatory blood pressure variability. Am J Hypertens. 2002 Nov;15(11):941-5. doi: 10.1016/s0895-7061(02)02999-0.
PubMed 12441212Modesti PA, Morabito M, Massetti L, Rapi S, Orlandini S, Mancia G, Gensini GF, Parati G. Seasonal blood pressure changes: an independent relationship with temperature and daylight hours. Hypertension. 2013 Apr;61(4):908-14. doi: 10.1161/HYPERTENSIONAHA.111.00315. Epub 2013 Feb 4.
PubMed 23381792
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
- HYPERTENSIVE CRISIS AND ATMOSPHERIC PRESSURE RELATIONSHIP: A PROSPECTIVE STUDY
- ClinicalTrials.gov ID
- NCT06635603
- Acronym / sponsor ID
- Hypertension, ATM pressure
- Conditions
- Hypertensive Urgency, Weather
- Keywords
- atmospheric pressure, hypertension, hypertensive urgency
- 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
- 15 Sep 2024 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 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.
relationship between the onset times of symptoms and the regions of patients presenting to the emergency department with hypertensive crisis (systolic ≥180 and/or diastolic ≥110 mmHg) and the fluctuations in atmospheric pressure
Detailed description
Hypertensive emergency is defined as grade 3 hypertension (systolic ≥180 and/or diastolic ≥110 mmHg) that causes end-organ damage, requiring urgent intervention and intensive care admission . Hypertensive crisis is described as severe hypertension not associated with end-organ damage. Some sources define hypertensive crisis as hypertension of grade 3 or higher, while others refer to it as severe hypertension without specifying a threshold .
Literature reviews, published guidelines, and studies indicate that the definitions and treatment approaches for hypertensive crisis differ between Europe and America, with variations in management from one physician to another . Seasonal blood pressure fluctuations are influenced by external temperature, indoor temperature, humidity, atmospheric pressure, and wind . Notably, during periods of low atmospheric pressure, blood pressure measurements show statistically significant increases compared to other days . Consequently, the frequency of life-threatening conditions associated with hypertension, such as intracranial hemorrhage and abdominal aortic aneurysm rupture, has been observed to increase on days when atmospheric pressure changes .
In our study, we aim to investigate the relationship between the onset times of symptoms and the regions of patients presenting to the emergency department with hypertensive crisis (systolic ≥180 and/or diastolic ≥110 mmHg) and the fluctuations in atmospheric pressure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypertension | – | –patients admitted to emergency department with grade 3 (systolic ≥180 and/or diastolic ≥110 mmHg) blood pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to emergency department with hypertensive urgency ( systolic ≥180 and/or diastolic ≥110 mmHg )
Key inclusion criteria (2 listed)
- Age 18 and above
- Hypertensive crisis (systolic ≥180 and/or diastolic ≥110 mmHg)
Key exclusion criteria (3 listed)
- Patients presenting with hypertensive emergency (those with end-organ damage)
- Patients who have traveled to another city or district within the last 4 days
- Pregnant patients
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
Hypertensive Crisis
Time frame: from enrollment to the end of follow up duration of 7 days
Patients' blood pressure values evaluation in terms of atmospheric pressure and weather conditions
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.
- Results publication: 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.
- Results publication: PubMed 12441212Jehn M, Appel LJ, Sacks FM, Miller ER 3rd; DASH Collaborative Research Group. The effect of ambient temperature and barometric pressure on ambulatory blood pressure variability. Am J Hypertens. 2002 Nov;15(11):941-5. doi: 10.1016/s0895-7061(02)02999-0.
- Results publication: PubMed 23381792Modesti PA, Morabito M, Massetti L, Rapi S, Orlandini S, Mancia G, Gensini GF, Parati G. Seasonal blood pressure changes: an independent relationship with temperature and daylight hours. Hypertension. 2013 Apr;61(4):908-14. doi: 10.1161/HYPERTENSIONAHA.111.00315. Epub 2013 Feb 4.
- Individual participant dataSharing planned: No
Related trials for Hypertensive Urgency
RecruitingPhase 2
Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
Hypertension, Acute Severe Hypertension
Recruiting
Home Hospital for Suddenly Ill Adults
Infection, Heart Failure
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.
Gulsen AKCAY, ass. prof. study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Urgency and Weather, run by Saglik Bilimleri Universitesi 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 2 inclusion and 3 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 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?
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?
Hypertensive Crisis (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 NCT06635603, 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.