Pre-capillary Pulmonary HypertensionNCT07176260
Exploring Blood Cell Function and Oxidative Stress to Improve Diagnosis and Treatment in Pre-Capillary Pulmonary Hypertension
An observational study of Pre-capillary Pulmonary Hypertension, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-capillary Pulmonary Hypertension
- What is being tested?
- Patients with pre-Capillary pulmonary hypertension
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prevalent or incident patients with pre-capillary pulmonary hypertension
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg - Service Physiologie explorations fonctionnelles
Strasbourg, Bas-Rhin, 67000
Marianne RIOU, +33 3 69 55 11 45, marianne.riou@chru-strasbourg.fr
About this study
Official title: Diagnostic and Prognostic Significance of Circulating Oxidative Stress and Blood Cell Mitochondrial Respiration 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.
- Conditions
- Pre-capillary Pulmonary Hypertension
- Being tested
- Patients with pre-Capillary pulmonary hypertension
- Keywords
- Mitochondrial respiration, Oxidative stress, PBMCs, platelets, Pulmonary arterial hypertension, Pulmonary hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with pre-Capillary pulmonary hypertensionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers
Analyse Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers
Measured: 3 years
Secondary outcomes (1)
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-capillary Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianne RIOU, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176260
- Sponsor's protocol ID
- CE 2017-24
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Significance of Circulating Oxidative Stress and Blood Cell Mitochondrial Respiration in Pre-Capillary Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07176260
- Acronym / sponsor ID
- CE 2017-24
- Conditions
- Pre-capillary Pulmonary Hypertension
- Keywords
- Mitochondrial respiration, Oxidative stress, PBMCs, platelets, Pulmonary arterial hypertension, Pulmonary hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prevalent or incident patients with pre-capillary pulmonary hypertension
Key inclusion criteria (7 listed)
- Adult patients (≥18 years) diagnosed with pre-capillary pulmonary hypertension confirmed by right heart catheterization
- Patients classified according to the international clinical classification:
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with pre-Capillary pulmonary hypertensionPatients 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. | Other | – |
Primary outcome
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
1 secondary outcome
Correlation of blood cell mitochondrial function and respirations and oxidative stress markers
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Pre-capillary Pulmonary Hypertension
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
A Clinical Study of Sotatercept (MK-7962) in People With Combined Postcapillary and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (MK-7962-041)
Pulmonary Hypertension
Recruiting
A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
Not yet recruitingPhase 1/2
TEPH: Telaglenastat Efficacy in Pulmonary Hypertension
Pulmonary Hypertension
Active, not recruitingPhase 2
Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
Hypertension, Pulmonary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marianne RIOU principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-capillary Pulmonary Hypertension, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianne RIOU (+ 33 3 69 55 11 45, marianne.riou@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.