Exploring Blood Cell Function and Oxidative Stress to Imp... | NCT07176260

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2025Estimated

Primary Completion Date

Sep 2025Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Sep 8, 2025

First Submission Date that Met QC Criteria

Sep 8, 2025

First Posted Date

Sep 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2025

Last Update Posted Date

Sep 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Correlation of blood cell mitochondrial function and respirations and oxidative stress markers	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	3 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Prevalent or incident patients with pre-capillary pulmonary hypertension

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marianne RIOU	Contact	+ 33 3 69 55 11 45		marianne.riou@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Marianne RIOU	Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpitaux Universitaires de Strasbourg - Service Physiologie explorations fonctionnelles	Recruiting	Strasbourg	Bas-Rhin	67000	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Description

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.

ID	Term
D000081029	Pulmonary Arterial Hypertension
D006976	Hypertension, Pulmonary

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases