NCT03707561

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

4.9 years

First QC Date

October 11, 2018

Last Update Submit

October 23, 2018

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • RHC

    Change of pulmonary vascular resistance

    12 month

Study Arms (7)

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)

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)

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)

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)

group 7- non-operable CTEPH

Non operable chronic thromboembolic pulmonary hypertension Diagnostic Test: Right Heart Catheterization (RHC)

Diagnostic Test: Right Heart Catheterization (RHC)

Interventions

Right Heart Catheterization (RHC)DIAGNOSTIC_TEST

RHC at the enrollment and every 12 months

Group 1 - IPAH and heritable PAHGroup 2- PAH associated with CHDGroup 3- PAH associated with CTDgroup 6- operable CTEPHgroup 7- non-operable CTEPH

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

IPAH and heritable PAH, PAH associated with CHD, PAH associated with CTD, portoPH, PAH-HIV, operable CTEPH, non-operable CTEPH

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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: 27735920BACKGROUND

  • 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: 27801422BACKGROUND

  • 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: 25518501BACKGROUND

  • 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: 30182153RESULT

  • 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.

    PMID: 25518507RESULT

Related Links

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Tamila Martynyuk, MD, PhD

    Russian Cardiology Research and Production Center

    PRINCIPAL INVESTIGATOR

  • Irina Chazova, MD, PhD

    Russian Cardiology Research and Production Center

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Russian Cardiology Research and Production Center

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 16, 2018

Study Start

January 1, 2016

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share