Registry of Arterial Hypertension

Sponsor
Federal State Budgetary Scientific Institution, Research Institute of Cardiology (Other)
Overall Status
Unknown status
CT.gov ID
NCT04160533
Collaborator
(none)
10,400
17
30
611.8
20.4

Study Details

Study Description

Brief Summary

The problem of the quality of primary health care medical system for patients with arterial hypertension is acute for the investigator's country, as these diseases are the most common and cause the high mortality of the population.

The concept of "quality of primary health care medical system" includes its timeliness, accessibility and provision of medical care to the patient at the modern level, which is determined by the degree of performance by doctors of medical and diagnostic measures corresponding current clinical recommendations.

The system of cardiovascular desease registries, established in the Federal State Clinical Hospital of the Russian Federation Ministry of Public Health with the automated analysis of data on examination and treatment, in comparison with clinical Recommendations. It makes possibility to identify shortcomings and develop approaches to improving the provision of medical care to patients in real clinical practice.

Comparative analysis of the quality of examination and treatment in different samples of patients with cardiovascular desease, observed in 2018-2020, compared with results of previous years will identify ptrends in the provision of medical care to patients with cardiovascular desease.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study will be conducted using the arterial hypertension registry method, which is a computer program with remote access that allows online collection medical data from medical primary care system. To minimize operator errors, doctors was trained before the work with the arterial hypertension registry. User's guide was developed and the rights of users was determined. Data of examination and treatment of patients from 18 years and older with an established diagnosis of hypertension will be added from outpatient cards into the registry of the arterial hypertension. The information is received by the Institution in an impersonal form through a certified dedicated security channel. Patients sign an informed consent for entering their medical data into the registry of arterial hypertension

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Registry of Arterial Hypertension: "Study of Modern Phenotypes of Arterial Hypertension, Including Secondary Forms, in Order to Create Personalized Methods of Treatment"
    Actual Study Start Date :
    Jun 1, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with blood pressure <140/90 mm Hg [2018 - 2021 years]

      The level of systolic and diastolic blood pressure measured according to the rules described in the clinical guidelines for the treatment and diagnosis of arterial hypertension of the European Society of Cardiology during the visit (mmHg) is entered into the database by doctors.

    Secondary Outcome Measures

    1. Number of patients with a history of myocardial infarction, chronic renal desease, chronic heart failure, atrial fibrillation. [2018-2021]

      Diagnosis data is entered by doctors as a "yes" or "no" category.

    2. Antihypertensive medications [2018-2021]

      Antihypertensive drugs the patient takes are entered into the database. Drugs are analyzed by groups and daily dosages

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: The diagnosis of arterial hypertension -

    Exclusion Criteria: No diagnosis of arterial hypertension

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regional state budgetary institution of health care Altai Regional Cardiology Dispensary State budgetary institution of public health "Volgograd regional clinical hospital No. 1" clinic State budgetary health institution of the Kemerovo region "Kemerovo R Barnaul Altai Russian Federation 656055
    2 State Healthcare Institution "Engels City Polyclinic No. 2 Engels Russian Federation
    3 State Healthcare Institution "Engels City Polyclinic No. 4 Engels Russian Federation
    4 State budgetary health institution of the Kemerovo region "Kemerovo Regional Clinical Cardiology Dispensary named after Academician L.S. Barbarash Kemerovo Russian Federation
    5 State budgetary institution of the ryazan region "regional clinical cardiological dispensary" Ryazan Russian Federation
    6 Municipal budgetary institution of public health "City polyclinic №1" Taganrog Branch №1 Taganrog Russian Federation
    7 Municipal budgetary institution of public health "City polyclinic №1" Taganrog Branch №2 Taganrog Russian Federation
    8 Municipal budgetary institution of public health "City polyclinic №1" Taganrog Branch №3 Taganrog Russian Federation
    9 Municipal budgetary institution of public health "City polyclinic №1" Taganrog Branch №4 Taganrog Russian Federation
    10 Municipal budgetary institution of public health "City polyclinic №2" Taganrog Branch №1 Taganrog Russian Federation
    11 Municipal budgetary institution of public health "City polyclinic №2" Taganrog Branch №4 Taganrog Russian Federation
    12 Municipal budgetary institution of public health services "City ambulance hospital" city of Taganrog Taganrog Russian Federation
    13 State Autonomous Healthcare Institution of the Tyumen Region "Tyumen Institute of Therapy Tyumen Russian Federation
    14 Municipal Health Institution "City Hospital No. 1" Volgodonsk Volgodonsk Russian Federation
    15 Municipal health institution "City polyclinic №1" Volgodonsk Volgodonsk Russian Federation
    16 Municipal health institution "City polyclinic №3" Volgodonsk Volgodonsk Russian Federation
    17 State budgetary institution of public health "Volgograd regional clinical hospital No. 1" clinic Volgograd Russian Federation

    Sponsors and Collaborators

    • Federal State Budgetary Scientific Institution, Research Institute of Cardiology

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Irina E. Chazova, Academician, scientific researcher, Department of Hypertension, Institute of Clinical Cardiology named after A.L.Myasnikov, National Medical Research Center of Cardiology of the Ministry of Healthcare of the Russian Federation, Federal State Budgetary Scientific Institution, Research Institute of Cardiology
    ClinicalTrials.gov Identifier:
    NCT04160533
    Other Study ID Numbers:
    • 86
    First Posted:
    Nov 13, 2019
    Last Update Posted:
    Nov 13, 2019
    Last Verified:
    Nov 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 13, 2019