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RUS-registry of PH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707561
Recruitment Status : Enrolling by invitation
First Posted : October 16, 2018
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
Scientific Research Institute of Rheumatology
Information provided by (Responsible Party):
Tamila V. Martynyuk, MD, PhD, Russian Cardiology Research and Production Center

Brief Summary:

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.

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).


Condition or disease Intervention/treatment
Pulmonary Hypertension Diagnostic Test: Right Heart Catheterization (RHC)

Detailed Description:

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

  • 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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Russian National Registry of Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021


Group/Cohort Intervention/treatment
Group 1 - IPAH and heritable PAH
Idiopathic pulmonary arterial hypertension (IPAH) and heritable PAH Diagnostic Test: Right Heart Catheterization (RHC)
Diagnostic Test: 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)
Diagnostic Test: 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)
Diagnostic Test: Right Heart Catheterization (RHC)
RHC at the enrollment and every 12 months

Group 4- portoPH
Portopulmonary hypertension
group 5- PAH-HIV
Pulmonary arterial hypertension associated with HIV infection
group 6- operable CTEPH
Operable chronic thromboembolic pulmonary hypertension Diagnostic Test: Right Heart Catheterization (RHC)
Diagnostic Test: 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)
Diagnostic Test: Right Heart Catheterization (RHC)
RHC at the enrollment and every 12 months




Primary Outcome Measures :
  1. RHC [ Time Frame: 12 month ]
    Change of pulmonary vascular resistance



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
IPAH and heritable PAH, PAH associated with CHD, PAH associated with CTD, portoPH, PAH-HIV, operable CTEPH, non-operable CTEPH
Criteria

Inclusion Criteria:

Newly diagnosed PAH:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707561


Sponsors and Collaborators
Russian Cardiology Research and Production Center
Scientific Research Institute of Rheumatology
Investigators
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Principal Investigator: Tamila Martynyuk, MD, PhD Russian Cardiology Research and Production Center
Study Chair: Irina Chazova, MD, PhD Russian Cardiology Research and Production Center
Study Director: Olga Arkhipova, PhD Russian Cardiology Research and Production Center
Study Director: Alexander Volkov, MD, PhD. Institute of Rheumatology named after VA Nasonova, Moscow, Russia
Study Director: Vera Lukyantchikova, MD, PhD Regional Clinical Hospital №1, Khabarovsk, Russia
Study Director: Elena Vetrova, PhD Belgorod Regional Clinical Hospital, Belgorod, Russia
Study Director: Elena Devitiyarova, MD, PhD Rostov Regional State CLINICAL HOSPITAL, Russia
Study Director: Olga Korolkova, MD, PhD Department of Hospital Therapy of the Voronezh State Medical Academy. N. N. Burdenko, Voronezh, Russia
Study Director: Olga Andreyeva State Healthcare Institution Regional Cardiology Dispensary, Ulyanovsk, Russia
Study Director: Svetlana Martynenko Regional Budget Cardiology Dispensary, Astrakhan, Russia
Study Director: Elena Milovanova, PhD District Cardiology Dispensary "Center for Diagnostic and Cardiovascular Surgery", Surgut, Russia
Study Director: Anna Rogacheva State Future Health Care Institution "Primorskaya Regional Clinical Hospital № 1", Vladivostok, Russia
Study Director: Svetlana Kharitonova State budgetary health care institution "Bryansk Regional Cardiology Dispensary", Bryansk, Russia
Study Director: Elena Shutemova, MD, PhD IVANOVO STATE MEDICAL ACADEMY Department of Therapy and General Practice, Ivanovo, Russia
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Tamila V. Martynyuk, MD, PhD, Russian Cardiology Research and Production Center
ClinicalTrials.gov Identifier: NCT03707561    
Other Study ID Numbers: NMIC for Cardiology
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases