Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-09 @ 10:42 AM
Study NCT ID:
NCT04160533
Status:
UNKNOWN
Last Update Posted:
2022-09-29
First Post:
2019-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10400}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2019-11-12', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with blood pressure <140/90 mm Hg', 'timeFrame': '2018 - 2021 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with a history of myocardial infarction, chronic renal desease, chronic heart failure, atrial fibrillation.', 'timeFrame': '2018-2021', 'description': 'Diagnosis data is entered by doctors as a "yes" or "no" category.'}, {'measure': 'Antihypertensive medications', 'timeFrame': '2018-2021', 'description': 'Antihypertensive drugs the patient takes are entered into the database. Drugs are analyzed by groups and daily dosages'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arterial Hypertension']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.\n\nComparative 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.', 'detailedDescription': "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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'outpatient patients from 18 to 99 years old with a diagnosis of hypertension', 'genderDescription': 'Participant eligibility is based on self-representation of gender identity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: The diagnosis of arterial hypertension -\n\nExclusion Criteria: No diagnosis of arterial hypertension\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04160533', 'briefTitle': 'Registry of Arterial Hypertension', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Medical Research Center for Cardiology, Ministry of Health of Russian Federation'}, 'officialTitle': 'Registry of Arterial Hypertension: "Study of Modern Phenotypes of Arterial Hypertension, Including Secondary Forms, in Order to Create Personalized Methods of Treatment"', 'orgStudyIdInfo': {'id': '86'}}, 'contactsLocationsModule': {'locations': [{'zip': '656055', 'city': 'Barnaul', 'state': 'Altayskiy Kray', 'status': 'RECRUITING', 'country': 'Russia', 'facility': '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', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'city': "Engel's", 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'State Healthcare Institution "Engels City Polyclinic No. 2', 'geoPoint': {'lat': 51.48389, 'lon': 46.10528}}, {'city': "Engel's", 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'State Healthcare Institution "Engels City Polyclinic No. 4', 'geoPoint': {'lat': 51.48389, 'lon': 46.10528}}, {'city': 'Kemerovo', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'State budgetary health institution of the Kemerovo region "Kemerovo Regional Clinical Cardiology Dispensary named after Academician L.S. Barbarash', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'city': 'Ryazan', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'State budgetary institution of the ryazan region "regional clinical cardiological dispensary"', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'city': 'Taganrog', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Municipal budgetary institution of public health "City polyclinic №1" Taganrog Branch №1', 'geoPoint': {'lat': 47.23627, 'lon': 38.9053}}, {'city': 'Taganrog', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Municipal budgetary institution of public health "City polyclinic №1" Taganrog Branch №2', 'geoPoint': {'lat': 47.23627, 'lon': 38.9053}}, {'city': 'Taganrog', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Municipal budgetary institution of public health "City polyclinic №1" Taganrog Branch №3', 'geoPoint': {'lat': 47.23627, 'lon': 38.9053}}, {'city': 'Taganrog', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Municipal budgetary institution of public health "City polyclinic №1" Taganrog Branch №4', 'geoPoint': {'lat': 47.23627, 'lon': 38.9053}}, {'city': 'Taganrog', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Municipal budgetary institution of public health "City polyclinic №2" Taganrog Branch №1', 'geoPoint': {'lat': 47.23627, 'lon': 38.9053}}, {'city': 'Taganrog', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Municipal budgetary institution of public health "City polyclinic №2" Taganrog Branch №4', 'geoPoint': {'lat': 47.23627, 'lon': 38.9053}}, {'city': 'Taganrog', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Municipal budgetary institution of public health services "City ambulance hospital" city of Taganrog', 'geoPoint': {'lat': 47.23627, 'lon': 38.9053}}, {'city': 'Tyumen', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'State Autonomous Healthcare Institution of the Tyumen Region "Tyumen Institute of Therapy', 'geoPoint': {'lat': 57.15222, 'lon': 65.52722}}, {'city': 'Volgodonsk', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Municipal Health Institution "City Hospital No. 1" Volgodonsk', 'geoPoint': {'lat': 47.51141, 'lon': 42.15269}}, {'city': 'Volgodonsk', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Municipal health institution "City polyclinic №1" Volgodonsk', 'geoPoint': {'lat': 47.51141, 'lon': 42.15269}}, {'city': 'Volgodonsk', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Municipal health institution "City polyclinic №3" Volgodonsk', 'geoPoint': {'lat': 47.51141, 'lon': 42.15269}}, {'city': 'Volgograd', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'State budgetary institution of public health "Volgograd regional clinical hospital No. 1" clinic', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}], 'centralContacts': [{'name': 'Anna Aksenova, MD', 'role': 'CONTACT', 'email': 'aksenovaannav@gmail.com', 'phone': '+74954146186'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Medical Research Center for Cardiology, Ministry of Health of Russian Federation', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': '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', 'investigatorFullName': 'Irina E. Chazova', 'investigatorAffiliation': 'Federal State Budgetary Scientific Institution, Research Institute of Cardiology'}}}}