Exploring Blood Cell Function and Oxidative Stress to Improve Diagnosis and Treatment in Pre-Capillary Pulmonary Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients with pre-Capillary pulmonary hypertension.
- Who it may be relevant to
- Registry conditions: Pre-capillary Pulmonary Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Diagnostic and Prognostic Significance of Circulating Oxidative Stress and Blood Cell Mitochondrial Respiration in Pre-Capillary Pulmonary Hypertension
Overview
This study aims to understand how blood cell (including peripheral blood mononuclear cells ((PBMCs) or platelets) function and oxidative stress can help physicians detect and predict the course of pre-capillary pulmonary hypertension. We hypothesize that changes in the mitochondrial function of blood cells and oxidative stress may be early markers of disease progression and severity. The study will also explore how these blood markers relate to routine clinical and heart function measurements, such as echocardiography, right heart catheterization, 6-minute walk tests, and functional status, to see if they can help monitor patients over time and guide personalized care. This is a non-interventional study. Blood samples will be collected during routine visits planned for diagnosis and follow-up. The study will include 120 patients diagnosed with pre-capillary pulmonary hypertension, who will be followed for 3 years. Blood samples will be taken up to three times per year to measure mainly oxidative stress and mitochondrial function in blood cells. These measurements will be compared with clinical tests to see if they can help predict the course of the disease.
Interventions
- Other Patients with pre-Capillary pulmonary hypertension
Patients will be followed for 3 years with routine clinical, hemodynamic, and laboratory assessments. Blood samples for oxidative stress and mitochondrial function analyses will be collected during scheduled follow-up visits or catheterization procedures. No intervention beyond standard care will be performed.
Primary outcome measures
- Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers [Time frame: 3 years]
Secondary outcome measures (1)
- Correlation of blood cell mitochondrial function and respirations and oxidative stress markers [Time frame: 3 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpitaux Universitaires de Strasbourg - Service Physiologie explorations fonctionnelles — Strasbourg
Identifiers
NCT: NCT07176260 · CE 2017-24