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:
Russian Cardiology Research and Production Center
Organization:
Study Overview
Official Title:
Russian National Registry of Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
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
* 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: