Ignite Creation Date:
2024-05-06 @ 12:13 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03707561
Status:
UNKNOWN
Last Update Posted:
2018-10-25
First Post:
2018-10-11
Brief Title:
RUS-registry of PH
Sponsor:
Russian Cardiology Research and Production Center
Organization:
Russian Cardiology Research and Production Center
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 wwwmedibasepro 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 wwwmedibasepro 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 PHpatients
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 PHpatients
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?:
None