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Risk Factors of Hypertensive Urgencies (OSADA)

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ClinicalTrials.gov Identifier: NCT00421239
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : December 9, 2008
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease
Hypertensive Urgency

Detailed 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).

Study Design

Study Type : Observational
Actual Enrollment : 1200 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Retrospective Study of Hypertensive Urgencies in Patients With Arterial Hypertension
Study Start Date : January 2007
Study Completion Date : December 2008
Groups and Cohorts

Group/Cohort
A
B


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants will be selected from hospital/policlinic database by random telephone dialing to every third patient who are diagnosed with arterial hypertension (SBP/DBP>140/90 Hg or taking antihypertensive drugs)
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421239


Locations
Russian Federation
Russian Cardiology Research and Production Center
Moscow, Russian Federation
Sponsors and Collaborators
Russian Cardiology Research and Production Center
KRKA
Investigators
Study Chair: Evgeniy I Chazov, MD Russian Cardiology Research and Production Center
More Information

Responsible Party: VNOK, Society of Cardiology of the Russian Federation
ClinicalTrials.gov Identifier: NCT00421239     History of Changes
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: December 9, 2008
Last Verified: December 2008

Keywords provided by Russian Cardiology Research and Production Center:
hypertensive urgency
arterial hypertension