Idiopathic Pulmonary Arterial HypertensionNCT06587074
Features of the Clinical Course and Prognosis in Patients With Idiopathic Pulmonary Hypertension When Using Modern Strategies of Specific Therapy
An observational study of Idiopathic Pulmonary Arterial Hypertension, run by Russian Cardiology Research and Production Center at 1 site in Russia.
Trial summary
This study will be performed based on a retrospective analysis of the cases of 150-170 patients with IPAH observed at the Research Institute of Clinical Cardiology over the past 10 years, for a comparative assessment of the survival of groups of patients with IPAH diagnosed in the period 2004-2013 and 2014-2023. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Arterial Hypertension
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 30 May 2023to 22 Jul 2025
- How long will I take part?
- 3 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IPAH diagnosed patients in 2004-2023
Who may be able to join
- age over 18 years;
- verified diagnosis of IPAH
Who cannot join
- age under 18 years;
- Other etiology op PAH,
- ischemic heart disease confirmed by MSCT of the coronary arteries or coronary angiography;
- diseases of the musculoskeletal system that prevent 6MWT
- severe liver dysfunction (more than 9 points on the Child-Pugh scale, class C)
- severe renal dysfunction (CC less than 15 ml/min), need for hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Features of the Clinical Course and Prognosis in Patients With Idiopathic Pulmonary
This study will be performed based on a retrospective analysis of the cases of 150-170 patients with IPAH observed at the Research Institute of Clinical Cardiology over the past 10 years, for a comparative assessment of the survival of groups of patients with IPAH diagnosed in the period 2004-2013 and 2014-2023.
The demographic, clinical, functional, hemodynamic characteristics of patients, comorbidity, blood biomarker levels, received PAH-specific and symptomatic therapy will be assessed in order to determine the clinical characteristics of patients with IPAH.
The prospective part of study will include 50 patients with IPAH.
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described | |
| Group 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality in 3 years after diagnosed IPAH
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 May 2023
- Primary completion14 Aug 2024
- Study completion22 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Arterial 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
- 150 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Russian Cardiology Research and Production Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamila V. Martynyuk, MD, PhD, Russian Cardiology Research and Production Center
- Investigators
- Tamila V Martyunuk, Yes, Principal investigator, Russian National Cardiology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587074
- Sponsor's protocol ID
- SHAM-3232
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Features of the Clinical Course and Prognosis in Patients With Idiopathic Pulmonary
- ClinicalTrials.gov ID
- NCT06587074
- Acronym / sponsor ID
- SHAM-3232
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Russian Cardiology Research and Production CenterUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 22 Jul 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
This study will be performed based on a retrospective analysis of the cases of 150-170 patients with IPAH observed at the Research Institute of Clinical Cardiology over the past 10 years, for a comparative assessment of the survival of groups of patients with IPAH diagnosed in the period 2004-2013 and 2014-2023.
The demographic, clinical, functional, hemodynamic characteristics of patients, comorbidity, blood biomarker levels, received PAH-specific and symptomatic therapy will be assessed in order to determine the clinical characteristics of patients with IPAH.
The prospective part of study will include 50 patients with IPAH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
| Group 2 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IPAH diagnosed patients in 2004-2023
Key inclusion criteria (2 listed)
- age over 18 years;
- verified diagnosis of IPAH
Key exclusion criteria (6 listed)
- age under 18 years;
- Other etiology op PAH,
- ischemic heart disease confirmed by MSCT of the coronary arteries or coronary angiography;
- diseases of the musculoskeletal system that prevent 6MWT
- severe liver dysfunction (more than 9 points on the Child-Pugh scale, class C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality in 3 years after diagnosed IPAH
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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 V Martyunuk, Yes principal investigator
Russian National Cardiology Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Arterial Hypertension, run by Russian Cardiology Research and Production Center at 1 site in Russia.
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 2 inclusion and 6 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Mortality in 3 years after diagnosed IPAH (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.