The Role of miRNA in Group 3 Pulmonary Hypertension

NCT06714136 | Active Not Recruiting

• 2 other identifiers: miRNA-GR3PHRC22000410
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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 mechanisms underlying pulmonary hypertension.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Study Arms (3)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Unsuitability of lung tissue for molecular biology investigations (due to preservation issues or deterioration of the necessary arteriolar structures).
• Patients with active neoplastic diseases.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS AOU Bologna

Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Lung tissue

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elena Salvaterra, MD, PhD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 3, 2024
• Study Start: October 10, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)