OSADA: Risk Factors of Hypertensive Urgencies

Sponsor
Russian Cardiology Research and Production Center (Other)
Overall Status
Completed
CT.gov ID
NCT00421239
Collaborator
KRKA (Industry)
1,200
1
23
52.2

Study Details

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 Intervention/Treatment Phase

    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 :
    Jan 1, 2007
    Actual Study Completion Date :
    Dec 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    A

    B

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 79 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00421239
      Other Study ID Numbers:
      • NCT00421239
      First Posted:
      Jan 11, 2007
      Last Update Posted:
      Dec 9, 2008
      Last Verified:
      Dec 1, 2008
      Keywords provided by , ,
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Dec 9, 2008