Pulmonary HypertensionmiRNA-GR3PHNCT06714136
The Role of miRNA in Group 3 Pulmonary Hypertension
An observational study of Pulmonary Hypertension, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This study recognizes the substantial value of lung tissue obtained from explanted lungs for fundamental research purposes.By analyzing pulmonary tissue affected by pulmonary hypertension, it is possible to discover shared pathogenetic mechanisms between these two groups and to gain a deeper understanding of the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2022to 20 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Tissue samples from lung explants of patients who underwent lung transplantation at IRCCS University Hospital of Bologna and at IRCCS San Matteo Hospital of Pavia from the 1st of January 2010 to the 31th of December 2021 were considered. Among 149 transplant performed in the two transplant center during the period of interest, we included in this study 27 patients who were submitted to single or double lung transplant with the following indications: idiopathic pulmonary arterial hypertension and idiopathic pulmonary fibrosis, or chronic obstructive pulmonary disease, both complicated by pulmonary arterial hypertension (defined as PAPm ≥ 25 mmHg) All patients underwent right heart catheterization during pre-transplant screening and had explanted lung samples available for the study.
Who may be able to join
- Patients who underwent lung transplantation at the AOU IRCCS Policlinico Sant'Orsola in Bologna and the IRCCS Fondazione Policlinico San Matteo in Pavia (satellite center) from January 1, 2010, to December 31, 2021.
- Diagnosis of idiopathic pulmonary arterial hypertension, idiopathic pulmonary fibrosis, or chronic obstructive pulmonary disease.
- Patients who underwent at least one pre-transplant right heart catheterization in clinically stable conditions, with findings of mPAP ≥ 25 mmHg, PVR > 3 WU, and PCP < 15 mmHg.
- Suitability of lung explant tissue available in the archives of the participating pathology departments: presence of at least 3 pulmonary arterioles in each specimen.
- Acquisition of informed consent. Exclusion criteria
- Unsuitability of lung tissue for molecular biology investigations (due to preservation issues or deterioration of the necessary arteriolar structures).
- Patients with active neoplastic diseases.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study recognizes the substantial value of lung tissue obtained from explanted lungs for fundamental research purposes.By analyzing pulmonary tissue affected by pulmonary hypertension, it is possible to discover shared pathogenetic mechanisms between these two groups and to gain a deeper understanding of the mechanisms underlying pulmonary hypertension.
Read the detailed description
Lung transplantation serves as the sole therapeutic approach targeting the enhancement of life expectancy and quality of life for individuals afflicted with advanced parenchymal or vascular lung diseases. The current study aligns with this objective, recognizing the substantial value of lung tissue obtained from explanted lungs for fundamental research purposes. By investigating lung tissue affected by both group 3 and group 1 pulmonary hypertension, it becomes possible to uncover shared pathogenic mechanisms between these two groups and gain a more profound understanding of the underlying mechanisms driving group 3 pulmonary hypertension. Furthermore, delving into the cells responsible for the expression of dysregulated miRNAs offers the potential to identify novel target mechanisms for the clinical management of group 3 pulmonary hypertension, an area currently limited in therapeutic options. Through a comparative analysis of the quantitative expression patterns of each miRNA among distinct groups, it becomes feasible to determine the extent of involvement of specific pathogenic pathways in the various forms of pulmonary hypertension. Consequently, this approach provides guidance for future research, directing focus towards the most relevant mechanisms of interest.
- Conditions
- Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
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 |
|---|---|---|
| PAH (idiopathic pulmonary hypertension) | Patients with idiopathic pulmonary hypertension | |
| IPF-PH (idiopathic pulmonary fibrosis and pulmonary hypertension) | Patients with idiopathic pulmonary fibrosis and pulmonary hypertension | |
| COPD-PH (COPD and pulmonary hypertension) | Patients with COPD and pulmonary hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNAs espression
expression of miRNAs underlying the development of pulmonary arterial hypertension shared between idiopathic pulmonary arterial hypertension and pulmonary arterial hypertension in patients with idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start10 Oct 2022
- Primary completion20 Dec 2023
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Salvaterra, MD, PhD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714136
- Sponsor's protocol ID
- miRNA-GR3PH
- Other IDs
- RC22000410
- Acronym
- miRNA-GR3PH
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of miRNA in Group 3 Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06714136
- Acronym / sponsor ID
- miRNA-GR3PH / miRNA-GR3PH
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 3 Dec 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 recognizes the substantial value of lung tissue obtained from explanted lungs for fundamental research purposes.By analyzing pulmonary tissue affected by pulmonary hypertension, it is possible to discover shared pathogenetic mechanisms between these two groups and to gain a deeper understanding of the mechanisms underlying pulmonary hypertension.
Detailed description
Lung transplantation serves as the sole therapeutic approach targeting the enhancement of life expectancy and quality of life for individuals afflicted with advanced parenchymal or vascular lung diseases. The current study aligns with this objective, recognizing the substantial value of lung tissue obtained from explanted lungs for fundamental research purposes. By investigating lung tissue affected by both group 3 and group 1 pulmonary hypertension, it becomes possible to uncover shared pathogenic mechanisms between these two groups and gain a more profound understanding of the underlying mechanisms driving group 3 pulmonary hypertension. Furthermore, delving into the cells responsible for the expression of dysregulated miRNAs offers the potential to identify novel target mechanisms for the clinical management of group 3 pulmonary hypertension, an area currently limited in therapeutic options. Through a comparative analysis of the quantitative expression patterns of each miRNA among distinct groups, it becomes feasible to determine the extent of involvement of specific pathogenic pathways in the various forms of pulmonary hypertension. Consequently, this approach provides guidance for future research, directing focus towards the most relevant mechanisms of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PAH (idiopathic pulmonary hypertension) | – | –Patients with idiopathic pulmonary hypertension |
| IPF-PH (idiopathic pulmonary fibrosis and pulmonary hypertension) | – | –Patients with idiopathic pulmonary fibrosis and pulmonary hypertension |
| COPD-PH (COPD and pulmonary hypertension) | – | –Patients with COPD and pulmonary hypertension |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tissue samples from lung explants of patients who underwent lung transplantation at IRCCS University Hospital of Bologna and at IRCCS San Matteo Hospital of Pavia from the 1st of January 2010 to the 31th of December 2021 were considered. Among 149 transplant performed in the two transplant center during the period of interest, we included in this study 27 patients who were submitted to single or double lung transplant with the following indications: idiopathic pulmonary arterial hypertension and idiopathic pulmonary fibrosis, or chronic obstructive pulmonary disease, both complicated by pulmonary arterial hypertension (defined as PAPm ≥ 25 mmHg) All patients underwent right heart catheterization during pre-transplant screening and had explanted lung samples available for the study.
Key inclusion criteria (7 listed)
- Patients who underwent lung transplantation at the AOU IRCCS Policlinico Sant'Orsola in Bologna and the IRCCS Fondazione Policlinico San Matteo in Pavia (satellite center) from January 1, 2010, to December 31, 2021.
- Diagnosis of idiopathic pulmonary arterial hypertension, idiopathic pulmonary fibrosis, or chronic obstructive pulmonary disease.
- Patients who underwent at least one pre-transplant right heart catheterization in clinically stable conditions, with findings of mPAP ≥ 25 mmHg, PVR > 3 WU, and PCP < 15 mmHg.
- Suitability of lung explant tissue available in the archives of the participating pathology departments: presence of at least 3 pulmonary arterioles in each specimen.
- Acquisition of informed consent. Exclusion criteria
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.
Primary outcome
miRNAs espression
Time frame: 18 months
expression of miRNAs underlying the development of pulmonary arterial hypertension shared between idiopathic pulmonary arterial hypertension and pulmonary arterial hypertension in patients with idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
Elena Salvaterra, MD, PhD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Pulmonary Hypertension, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Dec 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
miRNAs espression (time frame: 18 months). 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 5 Dec 2024.