Status:
COMPLETED
DNA Methylation Dynamics Underlying Arterial Remodeling in PAH Patients: CLEOPAHTRA Clinical Trial
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Pulmonary Arterial Hypertension
Pulmonary Arterial Remodeling
Eligibility:
All Genders
18-75 years
Brief Summary
To identify epigenetic-sensitive modifications and novel biomarkers linked to pathogenesis of pulmonary arterial hypertension (PAH), we will perform the first study analyzing differentially-methylated...
Detailed Description
Pulmonary arterial hypertension (PAH) is characterized by remodeling of pulmonary arteries caused by an inbalance of proliferation/apoptosis rate within the vascular wall. This pathological phenotype ...
Eligibility Criteria
Inclusion
- Newly diagnosed patients with World Health Organization (WHO) Group I PAH.
- ≥ 18 years
- Documentation of the following hemodynamic parameters by right heart catheterization, performed at time of study enrolment:
- Mean pulmonary arterial pressure (mPAP) \> 25 mmHg at rest or mPAP \> 30 mm Hg with exercise.
- Pulmonary arterial wedge pressure (PAWP) ≤ 15 mm Hg.
- Pulmonary vascular resistance (PVR) ≥ 240 dynes.sec.cm-5 (e.g., ≥ 3.0 Wood units)
Exclusion
- Patients who meet the criteria for inclusion into WHO Groups II, III, IV or V.
- Do not meet the required hemodynamic criteria for entry into the study.
- Patients with known history of cancer, malignancy disorders, active infections, and chronic or immune-mediated diseases.
Key Trial Info
Start Date :
June 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 14 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04282434
Start Date
June 14 2019
End Date
October 14 2020
Last Update
July 14 2021
Active Locations (1)
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1
Monaldi Hospital
Naples, Italy