Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-28 @ 6:35 AM
Study NCT ID:
NCT03707561
Status:
UNKNOWN
Last Update Posted:
2018-10-25
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RUS-registry of PH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2018-10-11', 'studyFirstSubmitQcDate': '2018-10-11', 'lastUpdatePostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RHC', 'timeFrame': '12 month', 'description': 'Change of pulmonary vascular resistance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '27735920', 'type': 'BACKGROUND', 'citation': 'Chazova IE, Martynyuk TV. [Clinical guidelines for the diagnosis and treatment of chronic thromboembolic pulmonary hypertension (Part 1)]. Ter Arkh. 2016;88(9):90-101. doi: 10.17116/terarkh201688990-101. Russian.'}, {'pmid': '27801422', 'type': 'BACKGROUND', 'citation': 'Chazova IE, Martynyuk TV. [Clinical guidelines for the diagnosis and treatment of chronic thromboembolic pulmonary hypertension (Part 2)]. Ter Arkh. 2016;88(10):63-73. doi: 10.17116/terarkh201688663-73. Russian.'}, {'pmid': '25518501', 'type': 'BACKGROUND', 'citation': 'Chazova IE, Avdeev SN, Tsareva NA, Volkov AV, Martyniuk TV, Nakonechnikov SN. [Clinical guidelines for the diagnosis and treatment of pulmonary hypertension]. Ter Arkh. 2014;86(9):4-23. Russian.'}, {'pmid': '30182153', 'type': 'RESULT', 'citation': 'Taran IN, Belevskaya AA, Saidova MA, Martynyuk TV, Chazova IE. Initial Riociguat Monotherapy and Transition from Sildenafil to Riociguat in Patients with Idiopathic Pulmonary Arterial Hypertension: Influence on Right Heart Remodeling and Right Ventricular-Pulmonary Arterial Coupling. Lung. 2018 Dec;196(6):745-753. doi: 10.1007/s00408-018-0160-4. Epub 2018 Sep 4.'}, {'pmid': '25518507', 'type': 'RESULT', 'citation': 'Chazova IE, Arkhipova OA, Valieva ZS, Nakonechnikov SN, Martyniuk TV. [Pulmonary hypertension in Russia: the first results of the national register]. Ter Arkh. 2014;86(9):56-64. Russian.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1097/01.hjh.0000467958.52984.9f', 'label': 'First date of Russian national registry of pulmonary arterial hypertension'}]}, 'descriptionModule': {'briefSummary': 'Russian National Registry of Patients With Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) is a multicenter, observational study of the clinical course and disease management of PAH and CTEPH patients. designed to gather demographic, clinical and prognostic data of routine medical care in prospective manner for newly initiated treatment since Jan 2016.\n\nThe internet-based registry (www.medibase.pro) fulfills high quality standards through several measures (planned minimum centre contribution of at least 10 patients per year, automated plausibility checks of data at entry, queries, monitoring with source data verification in \\>50% of participating centers).\n\nAll consecutive patients diagnosed with World Health Organization Pulmonary Hypertension Groups (WHO Group I) PAH according to specific hemodynamic criteria will be enrolled in participating centers after signing the informed consents. Participating patients will be followed for a minimum of five years from the time of enrollment.\n\nIt can be applied, among further purposes, for quality assurance: individual centers can confidentially compare their results with the combined outcome of the other centers. It is expected that the registry contributes to optimization of specific drug therapy for PAH and Pulmonary Hypertension (PH).', 'detailedDescription': 'Russian National Registry of Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension (RUS-registry of PH) will report current and comprehensive data on\n\n* Demographics, clinical course of incident PAH and CTEPH, the hemodynamic and functional status of patients\n* The main diagnostic approaches for the diagnosis of PAH and CTEPH.\n* Patient outcomes including survival, by subgroup, by treatment strategy and other factors\n* Clinical predictors of short-term and long-term clinical outcomes\n* Relationship between PAH- treatment medications and patient outcomes\n* Temporal trends in treatments and outcomes for newly diagnosed patients\n* The state of implementation of current PAH guidelines\n* To describe the status of operable or non-operable patients with PAH and CTEPH\n* To identify the most important prognostic indicators in patients with PH.\n* To study the basic principles of therapy of patients with PH.patients\n* To evolve research needs of the PAH community'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'IPAH and heritable PAH, PAH associated with CHD, PAH associated with CTD, portoPH, PAH-HIV, operable CTEPH, non-operable CTEPH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNewly diagnosed PAH:\n\nidiopathic form (IPAH) or PAH associated with connective tissue diseases (PAH-CTD), with congenital heart defects (PAH-CHD), with HIV infection (PAH-HIV), or portopulmonary hypertension Newly diagnosed CTEPH- operable and non-operable\n\nDocumentation of the following hemodynamic parameters by right heart catheterization, performed at the time of study enrollment:\n\nMean pulmonary arterial pressure (mPAP) ≥ 25 mm Hg at rest Pulmonary wedge pressure \\< 15 mm Hg Pulmonary vascular resistance (PVR) ≥ 240 dynes.sec.cm-5 (i.e., ≥ 3.0 Wood units) Signed informed consent Previously naïve patients with newly initiated therapy with endothelin receptor antagonists (ERA), phoshodiesterase-5 (PDE-5) inhibitors, soluble guanylate cyclase (sGC) stimulators or prostacyclins in mono- or combination therapy.'}, 'identificationModule': {'nctId': 'NCT03707561', 'briefTitle': 'RUS-registry of PH', 'organization': {'class': 'OTHER', 'fullName': 'Russian Cardiology Research and Production Center'}, 'officialTitle': 'Russian National Registry of Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'NMIC for Cardiology'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 - IPAH and heritable PAH', 'description': 'Idiopathic pulmonary arterial hypertension (IPAH) and heritable PAH Diagnostic Test: Right Heart Catheterization (RHC)', 'interventionNames': ['Diagnostic Test: Right Heart Catheterization (RHC)']}, {'label': 'Group 2- PAH associated with CHD', 'description': 'Pulmonary arterial hypertension associated with congenital heart disease Diagnostic Test: Right Heart Catheterization (RHC)', 'interventionNames': ['Diagnostic Test: Right Heart Catheterization (RHC)']}, {'label': 'Group 3- PAH associated with CTD', 'description': 'Pulmonary Arterial Hypertension associated with Connective Tissue Diseases Diagnostic Test: Right Heart Catheterization (RHC)', 'interventionNames': ['Diagnostic Test: Right Heart Catheterization (RHC)']}, {'label': 'Group 4- portoPH', 'description': 'Portopulmonary hypertension'}, {'label': 'group 5- PAH-HIV', 'description': 'Pulmonary arterial hypertension associated with HIV infection'}, {'label': 'group 6- operable CTEPH', 'description': 'Operable chronic thromboembolic pulmonary hypertension Diagnostic Test: Right Heart Catheterization (RHC)', 'interventionNames': ['Diagnostic Test: Right Heart Catheterization (RHC)']}, {'label': 'group 7- non-operable CTEPH', 'description': 'Non operable chronic thromboembolic pulmonary hypertension Diagnostic Test: Right Heart Catheterization (RHC)', 'interventionNames': ['Diagnostic Test: Right Heart Catheterization (RHC)']}], 'interventions': [{'name': 'Right Heart Catheterization (RHC)', 'type': 'DIAGNOSTIC_TEST', 'description': 'RHC at the enrollment and every 12 months', 'armGroupLabels': ['Group 1 - IPAH and heritable PAH', 'Group 2- PAH associated with CHD', 'Group 3- PAH associated with CTD', 'group 6- operable CTEPH', 'group 7- non-operable CTEPH']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tamila Martynyuk, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Russian Cardiology Research and Production Center'}, {'name': 'Irina Chazova, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Russian Cardiology Research and Production Center'}, {'name': 'Olga Arkhipova, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Russian Cardiology Research and Production Center'}, {'name': 'Alexander Volkov, MD, PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Rheumatology named after VA Nasonova, Moscow, Russia'}, {'name': 'Vera Lukyantchikova, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regional Clinical Hospital №1, Khabarovsk, Russia'}, {'name': 'Elena Vetrova, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Belgorod Regional Clinical Hospital, Belgorod, Russia'}, {'name': 'Elena Devitiyarova, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rostov Regional State CLINICAL HOSPITAL, Russia'}, {'name': 'Olga Korolkova, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Hospital Therapy of the Voronezh State Medical Academy. N. N. Burdenko, Voronezh, Russia'}, {'name': 'Olga Andreyeva', 'role': 'STUDY_DIRECTOR', 'affiliation': 'State Healthcare Institution Regional Cardiology Dispensary, Ulyanovsk, Russia'}, {'name': 'Svetlana Martynenko', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regional Budget Cardiology Dispensary, Astrakhan, Russia'}, {'name': 'Elena Milovanova, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'District Cardiology Dispensary "Center for Diagnostic and Cardiovascular Surgery", Surgut, Russia'}, {'name': 'Anna Rogacheva', 'role': 'STUDY_DIRECTOR', 'affiliation': 'State Future Health Care Institution "Primorskaya Regional Clinical Hospital № 1", Vladivostok, Russia'}, {'name': 'Svetlana Kharitonova', 'role': 'STUDY_DIRECTOR', 'affiliation': 'State budgetary health care institution "Bryansk Regional Cardiology Dispensary", Bryansk, Russia'}, {'name': 'Elena Shutemova, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IVANOVO STATE MEDICAL ACADEMY Department of Therapy and General Practice, Ivanovo, Russia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Russian Cardiology Research and Production Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scientific Research Institute of Rheumatology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Russian Cardiology Research and Production Center', 'investigatorFullName': 'Tamila V. Martynyuk, MD, PhD', 'investigatorAffiliation': 'Russian Cardiology Research and Production Center'}}}}