Risk Factors of Hypertensive Urgencies

Hypertensive Urgency Clinical Trial

— OSADA  

Official title:

Retrospective Study of Hypertensive Urgencies in Patients With Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421239
• Other study ID #: NCT00421239
• Status: Completed
• Phase: N/A
• First received: January 8, 2007
• Last updated: December 8, 2008
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: Russian Cardiology Research and Production Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether frequent hypertensive urgencies increase the risk of cardiovascular events in patients with arterial hypertension.

Description:

The spectrum of disorders associated with arterial hypertension (AH) encompasses chronic uncomplicated hypertension and the hypertensive crises, including hypertensive urgences and emergencies. Hypertensive crises accounted for more than 25% of all patient visits to a medical section of an emergency department, with hypertensive urgences (HU) accounting for two-third of these cases. Hypertensive crises, without prompt treatment, are often associated with morbidity and mortality. We propose to conduct a population-based case-control study of HU in areas of the Russian Federation. We will include about thirty study centers and one data coordinating center and will recruit study participants over a period of one years. We plan to conduct in-person interviews with 1,500 cases and 1,500 controls to elicit information on demographic background and history of exposures. We intend to test about 20-25 risk factors of HU thus calculated target number of subject is 3000 pts. We`re going to get access to hospital lists in each study center. From the database we`ll select patients with AH and recruit every third participant who came to hospital or/and policlinic. Every selected participant will be asked to respond to some questions by phone and be divided into two groups. Participants who have HU two weeks before the call will be questioned about level of arterial pressure and treatment during HU. Participants with often HU (every week or more) will be included into first group (prevalent cases, group A). Participants with seldom HU (every month or less) will be included into second group (controls, group B). Cases and controls will be selected from the same population of AH patients. Questionnaire contains information about age, gender, tobacco use, data about HU (frequency, treatment and its complications), antihypertensive and concomitant treatment, level of blood pressure, regularity of taking antihypertensive drugs, associated clinical conditions (cerebrovascular disease, heart disease, renal disease, peripheral vascular disease), PCI, CABG, if it be possible we intend to collect information of factors influencing prognosis (fasting plasma glucose, dyslipidaemia, serum creatinine, serum uric acid, left ventricular hypertrophy).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Cases: every third patient from hospital/policlinic database who are diagnosed with arterial hypertension (SBP/DBP>140/90 Hg or taking anti hypertensive drugs) and with frequent (weekly or daily) hypertensive urgencies (SBP/DBP=180/110 Hg) will be potentially eligible for the study.

• Controls will be selected from the same population of participants by random telephone dialing to every third patient with arterial hypertension (SBP/DBP>140/90 Hg or taking anti hypertensive drugs) and with seldom (monthly, several times in the year or never) hypertensive urgencies.

Exclusion Criteria:

• Hypertensive emergency

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypertension
• Hypertensive Urgency

Locations

Country	Name	City	State
Russian Federation	Russian Cardiology Research and Production Center	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Russian Cardiology Research and Production Center	KRKA

Country where clinical trial is conducted

Russian Federation,