Pulmonary Arterial HypertensionAuto-HTAPNCT01208792
Auto-immunity and Pulmonary Arterial Hypertension
A study testing skin biopsy and Blood Sample in people with Pulmonary Arterial Hypertension and HIV Infection, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
The investigators have recently evidenced the presence of antibodies to endothelial cells and fibroblasts in patients with idiopathic or SSc-associated PAH. The investigators also have identified several target antigens of anti-fibroblasts antibodies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension, HIV Infection, Congenital Heart Defect
- What is being tested?
- skin biopsy and Blood Sample
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 629 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Jun 2010to 15 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age over 18
- for PAH patients: pre-capillary PAH evidenced by right-heart catheterization
- no associated systemic disease for idiopathic PAH patients
- for HIV patients, HIV1 infection confirmed by ELISA and western blot
- for patients with porto pulmonary hypertension: evidence by endoscopy of esophageal varices, confirmation of hepatic venous pressure gradient over 5 mmHg by catheterization of the hepatic veins
- for patients with congenital heart defect: evidence by imaging of atrial or ventricular septal defect, or patent ductus arterious and confirmed by heart catheterization
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- patients with SSc will fulfill the American College of Rheumatology (ACR) and the LEROY and MEDSGER criteria
- patients with MCTD will fulfill the criteria for MCTD
- patients with SLE will fulfill the updated and revised ACR criteria
- patients with Sjögren's syndrome will fulfill the American-European consensus group criteria
- patients with chronic thromboembolic pulmonary hypertension: Lung scintiscan showing segmental mismatched perfusion defects and confirmation by angiography of the occlusion and the chance of success of endarterectomy according to the location of disease
- Signed written informed consent
- Patients with health insurance
Who cannot join
- age under 18
- pregnant women
- absence of written informed consent
- associated malignant tumor
Trial locations and contacts
3 sites in 1 country.
France3 sites
Pneumology Department, Antoine Béclère Hospital
Clamart, 92000
Internal Medicine Department, Claude Huriez Hospital
Lille, 59000
Internal Medicine Department, Cochin Hospital
Paris, 75014
About this study
Official title: Auto-immunity and Prognosis of Pulmonary Arterial Hypertension
The investigators have recently evidenced the presence of antibodies to endothelial cells and fibroblasts in patients with idiopathic or SSc-associated PAH. The investigators also have identified several target antigens of anti-fibroblasts antibodies.
The objective of this study is to further investigate for the presence of antibodies to endothelial cells and fibroblasts in patients and characterize the antigen specificity of autoantibodies in patients with different types of non idiopathic and non SSc-associated PAH, such as PAH associated with HIV infection, porto-pulmonary hypertension, congenital heart diseases, systemic lupus erythematosus, mixed connective tissue disease and Sjögren's syndrome
Read the detailed description
Two hundred and fifty patients with PAH will be included: 65 patients with idiopathic PAH (iPAH), 20 with PAH associated with HIV infection, 20 with porto-pulmonary hypertension, 20 with PAH secondary to congenital heart disorders, 40 with SSc, 20 with SLE, 20 with MCTD and 10 with a PAH associated with a Sjögren's syndrome.
Two hundred patients without PAH will also be included: 80 patients with SSc and 20 in each of the following groups: HIV infection, porto-pulmonary hypertension, SLE, congenital heart disorders, MCTD and with Sjögren's syndrome.
Twenty patients with proximal chronic thromboembolic pulmonary hypertension (CTPH) will also be included in a control arm of the study.
Two hundred and fifty healthy blood donors age and sex-matched with patients with PAH, will be included as controls.
By using 2D-immunoblotting techniques, we will evidence IgG antibodies to fibroblasts, EC, vascular smooth muscle cells (SMC) in multiple groups of patients and we will characterize target antigens of these autoantibodies. We will also assess the production of ROS: nitric oxide (NO), hydrogen peroxide (H2O2) and the effect of the whole serum (and the IgG particularly) on in VITRO proliferation of EC, fibroblasts and vascular SMC. For sera that will induce the production of ROS, we will study the effect of different vasodilatator (prostacycline, endothelin receptor antagonist, type 5 phosphodiesterase inhibitors) and anti-oxidant therapies.
Expected results We will characterize target antigens of autoantibodies of patients with non-idiopathic and non SSc-associated PAH. We will compare these target to those previously identified in idiopathic or SSc-associated PAH. We will then, distinguish subpopulations of PAH patients whose serum or purified IgG (possibly specific for a given antigen) are able to induce ROS production or cell proliferation. For the population of ROS-producer patients, we will correlate the clinical response to vasodilatator therapy to results of in VITRO inhibition experiments with vasodilatators and anti-oxidant molecules.
Perspectives The characterization of target antigens of EC, fibroblasts and vascular SMC specifically
- Conditions
- Pulmonary Arterial Hypertension, HIV Infection, Congenital Heart Defect, Systemic Sclerosis, Connective Tissue Disease
- Being tested
- skin biopsy, Blood Sample
- Keywords
- Auto antibodies, Target antigens, 2D-immunoblot, Reactive oxygen species, Pulmonary arterial hypertension, Systemic sclerosis, Human immunodeficiency virus infection, Porto pulmonary hypertension, Congenital heart defect, Systemic lupus erythematosus, Mixed connective tissue disease, Sjögren's syndrome
- Medical subject headings
- Pulmonary Arterial Hypertension, HIV Infections, Heart Defects, Congenital, Scleroderma, Systemic, Connective Tissue Diseases, Acquired Immunodeficiency Syndrome, Lupus Erythematosus, Systemic, Mixed Connective Tissue Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyProcedure or surgery
The biopsy site (usually the forearm) will be first cleaned, and then anesthetized with pain relieving (spray, cream, or injection). The skin is then sampled using a punch that takes a core (a small cylindrical fragment of tissue from the area of interest
Blood SampleOther
a blood sample will be collected
| Study group | Role | What they receive |
|---|---|---|
| Disease group | Experimental | Two hundred patients with PAH will be included: 50 patients with idiopathic PAH (iPAH), 20 with PAH associated with HIV infection, 20 with porto-pulmonary hypertension, 20 with PAH secondary to congenital heart disorders, 40 with SSc, 20 with SLE, 20 with MCTD and 10 with a PAH associated with a Sjögren's syndrome. Two hundred patients without PAH will also be included: 80 patients with SSc and 20 in each of the following groups: HIV infection, porto-pulmonary hypertension, SLE, congenital heart disorders, MCTD and with Sjögren's syndrome. Receives: Procedure: skin biopsy; Other: Blood Sample |
| Control group 1 | Other | Two hundred healthy blood donors age and sex-matched with patients with PAH, will be included as controls. Receives: Other: Blood Sample |
| Control group 2 | Other | Twenty patients with proximal chronic thromboembolic pulmonary hypertension (CTPH) will also be included in a control arm of the study. Receives: Other: Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological markers of prognosis interest in pulmonary arterial hypertension (PAH)
Measured: one year
Secondary outcomes (2)
Target antigens of autoantibodies
To characterize target antigens of autoantibodies in non-idiopathic and non-SSc associated PAH and to compare these target antigens to those recognized by autoantibodies directed at endothelial cells, fibroblasts and vascular smooth muscle cells in patients with idiopathic and SSc-associated PAH;
Measured: one year
Subpopulations of patients with PAH whose serum is able to induce the production of reactive oxygen species (ROS)
- To study and characterize subpopulations of patients with PAH whose serum is able to induce the production of reactive oxygen species (ROS) and/or cell proliferation.
- In patients in whom the whole serum induces cell proliferation and ROS production in cell cultures, to correlate the results of inhibition experiments in vivo in the presence of vasodilators used in the treatment of PAH and clinical response to these vasodilators
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study start15 Jun 2010
- Primary completion15 Jul 2014
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Luc Mouthon, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208792
- Sponsor's protocol ID
- P071209
- Acronym
- Auto-HTAP
- Status last verified
- Mar 2026
- First submitted
- 12 Jul 2010
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auto-immunity and Prognosis of Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01208792
- Acronym / sponsor ID
- Auto-HTAP / P071209
- Conditions
- Pulmonary Arterial Hypertension, HIV Infection, Congenital Heart Defect, Systemic Sclerosis, Connective Tissue Disease
- Keywords
- Auto antibodies, Target antigens, 2D-immunoblot, Reactive oxygen species, Pulmonary arterial hypertension, Systemic sclerosis, Human immunodeficiency virus infection, Porto pulmonary hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 Jun 2010 (actual)
- Primary completion
- 15 Jul 2014 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 24 Sep 2010 (estimated)
- 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.
The investigators have recently evidenced the presence of antibodies to endothelial cells and fibroblasts in patients with idiopathic or SSc-associated PAH. The investigators also have identified several target antigens of anti-fibroblasts antibodies.
The objective of this study is to further investigate for the presence of antibodies to endothelial cells and fibroblasts in patients and characterize the antigen specificity of autoantibodies in patients with different types of non idiopathic and non SSc-associated PAH, such as PAH associated with HIV infection, porto-pulmonary hypertension, congenital heart diseases, systemic lupus erythematosus, mixed connective tissue disease and Sjögren's syndrome
Detailed description
Two hundred and fifty patients with PAH will be included: 65 patients with idiopathic PAH (iPAH), 20 with PAH associated with HIV infection, 20 with porto-pulmonary hypertension, 20 with PAH secondary to congenital heart disorders, 40 with SSc, 20 with SLE, 20 with MCTD and 10 with a PAH associated with a Sjögren's syndrome.
Two hundred patients without PAH will also be included: 80 patients with SSc and 20 in each of the following groups: HIV infection, porto-pulmonary hypertension, SLE, congenital heart disorders, MCTD and with Sjögren's syndrome.
Twenty patients with proximal chronic thromboembolic pulmonary hypertension (CTPH) will also be included in a control arm of the study.
Two hundred and fifty healthy blood donors age and sex-matched with patients with PAH, will be included as controls.
By using 2D-immunoblotting techniques, we will evidence IgG antibodies to fibroblasts, EC, vascular smooth muscle cells (SMC) in multiple groups of patients and we will characterize target antigens of these autoantibodies. We will also assess the production of ROS: nitric oxide (NO), hydrogen peroxide (H2O2) and the effect of the whole serum (and the IgG particularly) on in VITRO proliferation of EC, fibroblasts and vascular SMC. For sera that will induce the production of ROS, we will study the effect of different vasodilatator (prostacycline, endothelin receptor antagonist, type 5 phosphodiesterase inhibitors) and anti-oxidant therapies.
Expected results We will characterize target antigens of autoantibodies of patients with non-idiopathic and non SSc-associated PAH. We will compare these target to those previously identified in idiopathic or SSc-associated PAH. We will then, distinguish subpopulations of PAH patients whose serum or purified IgG (possibly specific for a given antigen) are able to induce ROS production or cell proliferation. For the population of ROS-producer patients, we will correlate the clinical response to vasodilatator therapy to results of in VITRO inhibition experiments with vasodilatators and anti-oxidant molecules.
Perspectives The characterization of target antigens of EC, fibroblasts and vascular SMC specifically
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Disease group | Experimental | Procedure: skin biopsy, Other: Blood SampleTwo hundred patients with PAH will be included: 50 patients with idiopathic PAH (iPAH), 20 with PAH associated with HIV infection, 20 with porto-pulmonary hypertension, 20 with PAH secondary to congenital heart disorders, 40 with SSc, 20 with SLE, 20 with MCTD and 10 with a PAH associated with a Sjögren's syndrome. Two hundred patients without PAH will also be included: 80 patients with SSc and 20 in each of the following groups: HIV infection, porto-pulmonary hypertension, SLE, congenital heart disorders, MCTD and with Sjögren's syndrome. |
| Control group 1 | Other | Other: Blood SampleTwo hundred healthy blood donors age and sex-matched with patients with PAH, will be included as controls. |
| Control group 2 | Other | Other: Blood SampleTwenty patients with proximal chronic thromboembolic pulmonary hypertension (CTPH) will also be included in a control arm of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- age over 18
- for PAH patients: pre-capillary PAH evidenced by right-heart catheterization
- no associated systemic disease for idiopathic PAH patients
- for HIV patients, HIV1 infection confirmed by ELISA and western blot
- for patients with porto pulmonary hypertension: evidence by endoscopy of esophageal varices, confirmation of hepatic venous pressure gradient over 5 mmHg by catheterization of the hepatic veins
Key exclusion criteria (4 listed)
- age under 18
- pregnant women
- absence of written informed consent
- associated malignant tumor
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 |
|---|---|---|
| skin biopsyThe biopsy site (usually the forearm) will be first cleaned, and then anesthetized with pain relieving (spray, cream, or injection). The skin is then sampled using a punch that takes a core (a small cylindrical fragment of tissue from the area of interest | Procedure or surgery | Disease group |
| Blood Samplea blood sample will be collected | Other | Control group 1, Control group 2, Disease group |
Primary outcome
Immunological markers of prognosis interest in pulmonary arterial hypertension (PAH)
Time frame: one year
2 secondary outcomes
Target antigens of autoantibodies
Time frame: one year
Subpopulations of patients with PAH whose serum is able to induce the production of reactive oxygen species (ROS)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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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. This study is not recruiting at the moment.
Luc Mouthon, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy and Blood Sample in people with Pulmonary Arterial Hypertension and HIV Infection, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 13 inclusion and 4 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological markers of prognosis interest in pulmonary arterial hypertension (PAH) (time frame: one year). 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 27 Mar 2026.