Pulmonary HypertensionNCT03707561
RUS-registry of PH
An observational study of Pulmonary Hypertension, run by Russian Cardiology Research and Production Center.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Right Heart Catheterization (RHC)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2021
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: IPAH and heritable PAH, PAH associated with CHD, PAH associated with CTD, portoPH, PAH-HIV, operable CTEPH, non-operable CTEPH
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
Official title: Russian National Registry of Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension
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).
Read more
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).
Read the 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
- Conditions
- Pulmonary Hypertension
- Being tested
- Right Heart Catheterization (RHC)
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Heart Catheterization (RHC)Diagnostic test
RHC at the enrollment and every 12 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - IPAH and heritable PAH | Idiopathic pulmonary arterial hypertension (IPAH) and heritable PAH Diagnostic Test: Right Heart Catheterization (RHC) Receives: 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) Receives: 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) Receives: 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) Receives: Diagnostic Test: Right Heart Catheterization (RHC) | |
| group 7- non-operable CTEPH | Non operable chronic thromboembolic pulmonary hypertension Diagnostic Test: Right Heart Catheterization (RHC) Receives: Diagnostic Test: Right Heart Catheterization (RHC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RHC
Change of pulmonary vascular resistance
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study startJan 2016
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Russian Cardiology Research and Production Center
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Research Institute of Rheumatology
- Responsible party
- Principal investigator, Tamila V. Martynyuk, MD, PhD, Russian Cardiology Research and Production Center
- Investigators
- Tamila Martynyuk, MD, PhD, Principal investigator, Russian Cardiology Research and Production CenterIrina Chazova, MD, PhD, Study chair, Russian Cardiology Research and Production CenterOlga Arkhipova, PhD, Study director, Russian Cardiology Research and Production CenterAlexander Volkov, MD, PhD., Study director, Institute of Rheumatology named after VA Nasonova, Moscow, RussiaVera Lukyantchikova, MD, PhD, Study director, Regional Clinical Hospital №1, Khabarovsk, RussiaElena Vetrova, PhD, Study director, Belgorod Regional Clinical Hospital, Belgorod, RussiaElena Devitiyarova, MD, PhD, Study director, Rostov Regional State CLINICAL HOSPITAL, RussiaOlga Korolkova, MD, PhD, Study director, Department of Hospital Therapy of the Voronezh State Medical Academy. N. N. Burdenko, Voronezh, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707561
- Sponsor's protocol ID
- NMIC for Cardiology
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27735920Chazova 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.
PubMed 27801422Chazova 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.
PubMed 25518501Taran 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.
PubMed 30182153Chazova 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.
PubMed 25518507
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Russian National Registry of Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03707561
- Acronym / sponsor ID
- NMIC for Cardiology
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Russian Cardiology Research and Production CenterUniversity, hospital or other
- Collaborators
- Scientific Research Institute of Rheumatology
- Study start
- Jan 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1 - IPAH and heritable PAH | – | Diagnostic Test: Right Heart Catheterization (RHC)Idiopathic pulmonary arterial hypertension (IPAH) and heritable PAH Diagnostic Test: Right Heart Catheterization (RHC) |
| Group 2- PAH associated with CHD | – | Diagnostic Test: Right Heart Catheterization (RHC)Pulmonary arterial hypertension associated with congenital heart disease Diagnostic Test: Right Heart Catheterization (RHC) |
| Group 3- PAH associated with CTD | – | Diagnostic Test: Right Heart Catheterization (RHC)Pulmonary Arterial Hypertension associated with Connective Tissue Diseases 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 | – | Diagnostic Test: Right Heart Catheterization (RHC)Operable chronic thromboembolic pulmonary hypertension Diagnostic Test: Right Heart Catheterization (RHC) |
| group 7- non-operable CTEPH | – | Diagnostic Test: Right Heart Catheterization (RHC)Non operable chronic thromboembolic pulmonary hypertension Diagnostic Test: Right Heart Catheterization (RHC) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- IPAH and heritable PAH, PAH associated with CHD, PAH associated with CTD, portoPH, PAH-HIV, operable CTEPH, non-operable CTEPH
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right Heart Catheterization (RHC)RHC at the enrollment and every 12 months | Diagnostic test | Group 1 - IPAH and heritable PAH, Group 2- PAH associated with CHD, Group 3- PAH associated with CTD, group 6- operable CTEPH, group 7- non-operable CTEPH |
Primary outcome
RHC
Time frame: 12 month
Change of pulmonary vascular resistance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Background: PubMed 27735920Chazova 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.
- Background: PubMed 27801422Chazova 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.
- Background: PubMed 25518501Chazova 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.
- Results publication: PubMed 30182153Taran 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.
- Results publication: PubMed 25518507Chazova 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.
- First date of Russian national registry of pulmonary arterial hypertensionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamila Martynyuk, MD, PhD principal investigator
Russian Cardiology Research and Production Center
Irina Chazova, MD, PhD study chair
Russian Cardiology Research and Production Center
Olga Arkhipova, PhD study director
Russian Cardiology Research and Production Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Russian Cardiology Research and Production Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RHC (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03707561, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.