Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2016-01-31
2021-01-31
Brief Summary
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The 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).
All 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.
It 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).
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Detailed Description
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* Demographics, clinical course of incident PAH and CTEPH, the hemodynamic and functional status of patients
* The main diagnostic approaches for the diagnosis of PAH and CTEPH.
* Patient outcomes including survival, by subgroup, by treatment strategy and other factors
* Clinical predictors of short-term and long-term clinical outcomes
* Relationship between PAH- treatment medications and patient outcomes
* Temporal trends in treatments and outcomes for newly diagnosed patients
* The state of implementation of current PAH guidelines
* To describe the status of operable or non-operable patients with PAH and CTEPH
* To identify the most important prognostic indicators in patients with PH.
* To study the basic principles of therapy of patients with PH.patients
* To evolve research needs of the PAH community
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1 - IPAH and heritable PAH
Idiopathic pulmonary arterial hypertension (IPAH) and heritable PAH Diagnostic Test: Right Heart Catheterization (RHC)
Right Heart Catheterization (RHC)
RHC at the enrollment and every 12 months
Group 2- PAH associated with CHD
Pulmonary arterial hypertension associated with congenital heart disease Diagnostic Test: Right Heart Catheterization (RHC)
Right Heart Catheterization (RHC)
RHC at the enrollment and every 12 months
Group 3- PAH associated with CTD
Pulmonary Arterial Hypertension associated with Connective Tissue Diseases Diagnostic Test: Right Heart Catheterization (RHC)
Right Heart Catheterization (RHC)
RHC at the enrollment and every 12 months
Group 4- portoPH
Portopulmonary hypertension
No interventions assigned to this group
group 5- PAH-HIV
Pulmonary arterial hypertension associated with HIV infection
No interventions assigned to this group
group 6- operable CTEPH
Operable chronic thromboembolic pulmonary hypertension Diagnostic Test: Right Heart Catheterization (RHC)
Right Heart Catheterization (RHC)
RHC at the enrollment and every 12 months
group 7- non-operable CTEPH
Non operable chronic thromboembolic pulmonary hypertension Diagnostic Test: Right Heart Catheterization (RHC)
Right Heart Catheterization (RHC)
RHC at the enrollment and every 12 months
Interventions
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Right Heart Catheterization (RHC)
RHC at the enrollment and every 12 months
Eligibility Criteria
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Inclusion Criteria
idiopathic 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
Documentation of the following hemodynamic parameters by right heart catheterization, performed at the time of study enrollment:
Mean 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.
ALL
No
Sponsors
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Scientific Research Institute of Rheumatology
UNKNOWN
Russian Cardiology Research and Production Center
OTHER
Responsible Party
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Tamila V. Martynyuk, MD, PhD
Russian Cardiology Research and Production Center
Principal Investigators
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Tamila Martynyuk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Russian Cardiology Research and Production Center
Irina Chazova, MD, PhD
Role: STUDY_CHAIR
Russian Cardiology Research and Production Center
Olga Arkhipova, PhD
Role: STUDY_DIRECTOR
Russian Cardiology Research and Production Center
Alexander Volkov, MD, PhD.
Role: STUDY_DIRECTOR
Institute of Rheumatology named after VA Nasonova, Moscow, Russia
Vera Lukyantchikova, MD, PhD
Role: STUDY_DIRECTOR
Regional Clinical Hospital №1, Khabarovsk, Russia
Elena Vetrova, PhD
Role: STUDY_DIRECTOR
Belgorod Regional Clinical Hospital, Belgorod, Russia
Elena Devitiyarova, MD, PhD
Role: STUDY_DIRECTOR
Rostov Regional State CLINICAL HOSPITAL, Russia
Olga Korolkova, MD, PhD
Role: STUDY_DIRECTOR
Department of Hospital Therapy of the Voronezh State Medical Academy. N. N. Burdenko, Voronezh, Russia
Olga Andreyeva
Role: STUDY_DIRECTOR
State Healthcare Institution Regional Cardiology Dispensary, Ulyanovsk, Russia
Svetlana Martynenko
Role: STUDY_DIRECTOR
Regional Budget Cardiology Dispensary, Astrakhan, Russia
Elena Milovanova, PhD
Role: STUDY_DIRECTOR
District Cardiology Dispensary "Center for Diagnostic and Cardiovascular Surgery", Surgut, Russia
Anna Rogacheva
Role: STUDY_DIRECTOR
State Future Health Care Institution "Primorskaya Regional Clinical Hospital № 1", Vladivostok, Russia
Svetlana Kharitonova
Role: STUDY_DIRECTOR
State budgetary health care institution "Bryansk Regional Cardiology Dispensary", Bryansk, Russia
Elena Shutemova, MD, PhD
Role: STUDY_DIRECTOR
IVANOVO STATE MEDICAL ACADEMY Department of Therapy and General Practice, Ivanovo, Russia
References
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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.
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.
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.
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.
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.
Related Links
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First date of Russian national registry of pulmonary arterial hypertension
Other Identifiers
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NMIC for Cardiology
Identifier Type: -
Identifier Source: org_study_id
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