Blood cell mitochondrial function and oxidative stress in pre-capillary pulmonary hypertension
Diagnostic and Prognostic Significance of Circulating Oxidative Stress and Blood Cell Mitochondrial Respiration in Pre-Capillary Pulmonary Hypertension
University Hospital, Strasbourg, France · NCT07176260
This project will test whether changes in mitochondrial function of blood cells and oxidative stress can help detect and predict disease course in adults with pre-capillary pulmonary hypertension.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France (other) |
| Locations | 1 site (Strasbourg, Bas-Rhin) |
| Trial ID | NCT07176260 on ClinicalTrials.gov |
What this trial studies
This is an observational, non-interventional study enrolling 120 adults with right-heart-catheterization–confirmed pre-capillary pulmonary hypertension who will be followed for three years. Blood samples (PBMCs and platelets) will be collected up to three times per year during routine visits to measure mitochondrial respiration and markers of oxidative stress. Those blood measures will be compared with standard clinical and cardiac function data such as echocardiography, right heart catheterization, six-minute walk tests, and functional status. The goal is to determine whether circulating blood-cell signatures track disease severity or progression and could inform more personalized monitoring.
Who should consider this trial
Good fit: Adults (≥18) with pre-capillary pulmonary hypertension confirmed by right-heart catheterization who can attend routine follow-up visits at the Strasbourg center and consent to repeat blood draws are ideal candidates.
Not a fit: Patients with postcapillary pulmonary hypertension, those with conditions preventing safe blood draws, or those enrolled in interventional trials affecting mitochondrial or oxidative pathways are unlikely to benefit from these biomarkers.
Why it matters
Potential benefit: If successful, blood-cell mitochondrial and oxidative stress markers could enable earlier detection and help personalize monitoring and treatment decisions for people with pre-capillary pulmonary hypertension.
How similar studies have performed: Previous research has documented mitochondrial dysfunction and oxidative stress in pulmonary arterial hypertension, but using blood-cell mitochondrial measures as clinical diagnostic or prognostic markers remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years) diagnosed with pre-capillary pulmonary hypertension confirmed by right heart catheterization * Patients classified according to the international clinical classification: * Group 1: Pulmonary arterial hypertension (PAH) * Group 3: Pulmonary hypertension associated with chronic respiratory diseases and/or hypoxia * Group 4: Chronic thromboembolic pulmonary hypertension (CTEPH) * Patients scheduled for routine clinical follow-up and/or right heart catheterization at the study center. * Ability and willingness to provide informed consent for participation and data analysis. Exclusion Criteria: * Postcapillary pulmonary hypertension (pulmonary arterial wedge pressure \>15 mmHg). * Conditions precluding safe blood sampling (e.g., severe anemia, coagulopathy). * Patients already enrolled in interventional clinical trials that could interfere with mitochondrial or oxidative stress measurements * Patients unable or unwilling to provide informed consent * Pregnancy or breastfeeding
Where this trial is running
Strasbourg, Bas-Rhin
- Hôpitaux Universitaires de Strasbourg - Service Physiologie explorations fonctionnelles — Strasbourg, Bas-Rhin, France (RECRUITING)
Study contacts
- Principal investigator: Marianne RIOU — Hôpitaux Universitaires de Strasbourg
- Study coordinator: Marianne RIOU
- Email: marianne.riou@chru-strasbourg.fr
- Phone: + 33 3 69 55 11 45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pre-capillary Pulmonary Hypertension, Mitochondrial respiration, Oxidative stress, PBMCs, platelets, Pulmonary arterial hypertension, Pulmonary hypertension