Risk Factors of Hypertensive Urgencies

NCT ID: NCT00421239

Last Updated: 2008-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertensive Urgency

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hypertensive urgency arterial hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

No interventions assigned to this group

B

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KRKA

INDUSTRY

Sponsor Role collaborator

Russian Cardiology Research and Production Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Society of Cardiology of the Russian Federation

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Evgeniy I Chazov, MD

Role: STUDY_CHAIR

Russian Cardiology Research and Production Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Russian Cardiology Research and Production Center

Moscow, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCT00421239

Identifier Type: -

Identifier Source: org_study_id