Exploring Blood Cell Function and Oxidative Stress to Improve Diagnosis and Treatment in Pre-Capillary Pulmonary Hypertension

NCT07176260 | Recruiting

• 1 other identifier: CE 2017-24
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-capillary Pulmonary Hypertension

Keywords

Mitochondrial respiration; Oxidative stress; PBMCs, platelets; Pulmonary arterial hypertension; Pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers

  Analyse Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers

  3 years

Secondary Outcomes (1)

• Correlation of blood cell mitochondrial function and respirations and oxidative stress markers

  3 years

Interventions

Patients with pre-Capillary pulmonary hypertension OTHER

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.

Eligibility Criteria

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

Study Population

Prevalent or incident patients with pre-capillary pulmonary hypertension

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg - Service Physiologie explorations fonctionnelles

Strasbourg, Bas-Rhin, 67000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Whole blood - collected from peripheral veins or from jugular vein during right heart catheterization. * Plasma/serum - separated from blood samples for biochemical and oxidative stress analyses. * White blood cells (PBMCs) - isolated from whole blood for mitochondrial respiration studies and related assays. * Platelets - isolated from whole blood for mitochondrial respiration studies and related assays. * Arterialized and arterial blood - obtained from the pulmonary artery occlusion site during catheterization for comparative mitochondrial and oxidative stress analyses No other biospecimens (e.g., urine, tissue) will be collected or retained.

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

• Marianne RIOU

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne RIOU

CONTACT

+ 33 3 69 55 11 45; marianne.riou@chru-strasbourg.fr

Study Design

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

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 16, 2025
• Study Start: September 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

FR (1)