HYPERTENSIVE CRISIS AND ATMOSPHERIC PRESSURE RELATIONSHIP | NCT06635603

Studies
HYPERTENSIVE CRISIS AND ATMOSPHERIC PRESSURE RELATIONSHIP

NCT06635603

Sponsor

Saglik Bilimleri Universitesi

Status

Recruiting

Last Update Posted

Oct 10, 2024Actual

Enrollment

350Estimated

Phase

Not provided

Conditions

Hypertensive Urgency
Weather

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2024Actual

Primary Completion Date

Sep 15, 2025Estimated

Completion Date

Sep 15, 2025Estimated

First Submitted Date

Oct 8, 2024

First Submission Date that Met QC Criteria

Oct 8, 2024

First Posted Date

Oct 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2024

Last Update Posted Date

Oct 10, 2024Actual

Name	Class
Etimesgut Military Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

7 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hypertension		patients admitted to emergency department with grade 3 (systolic ≥180 and/or diastolic ≥110 mmHg) blood pressure

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypertensive Crisis	Patients' blood pressure values evaluation in terms of atmospheric pressure and weather conditions	from enrollment to the end of follow up duration of 7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 and above
Hypertensive crisis (systolic ≥180 and/or diastolic ≥110 mmHg)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to emergency department with hypertensive urgency ( systolic ≥180 and/or diastolic ≥110 mmHg )

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gulsen AKCAY, Ass. Prof.	Contact	+905052874949		gulakcay@yahoo.com.tr
Elif HAMZACEBIOGLU KAYISOGLU, Specialist	Contact	+905453300679		turkuaz-61@indowslive.com

Overall Officials

Name	Affiliation	Role
Gulsen AKCAY, ass. prof.	Ankara Etlik City Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Etlik City Hospital	Recruiting	Ankara		06170	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31415308	Result	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.
12441212	Result	Jehn 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.

ID	Term
D000096003	Hypertensive Crisis
D006973	Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases