RUS-registry of PH

Pulmonary Hypertension Clinical Trial

Official title:

Russian National Registry of Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03707561
• Other study ID #: NMIC for Cardiology
• Status: Enrolling by invitation
• Start date: January 2016
• Est. completion date: January 2021

Study information

• Verified date: October 2018
• Source: Russian Cardiology Research and Production Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Diagnostic Test:
• Right Heart Catheterization (RHC)
RHC at the enrollment and every 12 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Russian Cardiology Research and Production Center	Scientific Research Institute of Rheumatology

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RHC	Change of pulmonary vascular resistance	12 month

External Links

•   Comparative analysis of the demographic and clinical characteristics of patients with idiopathic pulmonary arterial hypertension associated with systemic scleroderma according to the data of the Russian National Registry
•   Comparative assessment of the demographic characteristics and functional ability of patients with PAH in the Russian registry and the largest foreign registers.
•   Features of pulmonary arterial hypertension according to the Russian Register.
•   First date of Russian national registry of pulmonary arterial hypertension
•   First results of a clinical analysis of patients with chronic thromboembolic pulmonary hypertension depending on their operability status according to the data of the Russian pulmonary hypertension register.
•   Hemodynamic and functional characteristics of patients with different forms of pulmonary arterial hypertension according to the russian registration of patients with pulmonary hypertension.