Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07176260

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pre-capillary Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaires de Strasbourg - Service Physiologie explorations fonctionnelles

Strasbourg, Bas-Rhin, 67000, France

Location status: Recruiting

Location contact

Marianne RIOU

CONTACT

[email protected]

+33 3 69 55 11 45

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers

    Time frame: 3 years

    Analyse Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers

Secondary outcomes

  1. Correlation of blood cell mitochondrial function and respirations and oxidative stress markers

    Time frame: 3 years

    Correlation of blood cell mitochondrial function and respirations and oxidative stress markers with routine clinical and hemodynamic parameters, including echocardiography, right heart catheterization, 6-minute walk test (6MWT), NYHA functional class, and BNP or NT-pro BNP levels

Study contacts

Contact information is provided by the study sponsor or research team.

Marianne RIOU

CONTACT

[email protected]

+ 33 3 69 55 11 45

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Diagnostic and Prognostic Significance of Circulating Oxidative Stress and Blood Cell Mitochondrial Respiration in Pre-Capillary Pulmonary Hypertension

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.