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Idiopathic Pulmonary Arterial HypertensionNCT02959723

Physiopathology of Pulmonary Arterial Hypertension: Mechanistic Studies

An observational study of Idiopathic Pulmonary Arterial Hypertension, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The current aims to combine analysis of different inflammatory biomarkers and BMPR2 mutations, which are currently analyzed in each patient diagnosed with idiopathic or familial PAH, to establish an earlier diagnosis and consequently better orientate the therapeutic strategy in PAH. Read more about this study

Who is it for?
Ages 15 to 80 years
How many people
100 participants
Where
1 siteBelgium
Study dates
Jan 2015to Dec 2020
Phase
Observational
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 15 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with Idiopathic Pulmonary Arterial Hypertension undergoing right heart catheterization and/or lung transplantation

Who may be able to join

  • Idiopathic Pulmonary Arterial Hypertension

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Belgium1 site, 1 recruiting
  • UZ Leuven Campus Gasthuisberg

    Leuven, 3000

    Rozenn Quarck, PhD, +3216340962, rozennanne.quarck@uzleuven.be

    Recruiting

Other trials in Belgium

About this study

The current aims to combine analysis of different inflammatory biomarkers and BMPR2 mutations, which are currently analyzed in each patient diagnosed with idiopathic or familial PAH, to establish an earlier diagnosis and consequently better orientate the therapeutic strategy in PAH.

Read the detailed description

BACKGROUND

Pulmonary hypertension is a severe disorder defined by an elevated mean pulmonary arterial pressure (mPAP) as >25 mmHg at rest. A classification of the different types of pulmonary hypertension has been established according to shared pathologic and clinical features as well as similar therapeutic options and recently updated. Five major categories have been defined including 1) pulmonary arterial hypertension (PAH), 2) PH owing to left heart diseases, 3) PH owing to lung diseases and/or hypoxia, 4) chronic thromboembolic PH (CTEPH) and 5) PH with unclear multifactorial mechanisms.

PAH commonly defined by an elevated PAP (>25 mmHg at rest) and a normal pulmonary arterial wedge pressure (<15 mmHg), is characterized by a pre-capillary arteriopathy with the presence of vascular remodeling and formation of plexiform lesions, an increased pulmonary vascular resistance (PVR), which may result in right heart failure. PAH may be idiopathic (IPAH), heritable (HPAH) or associated with drug/toxin exposure or other medical conditions including connective tissue diseases, congenital heart diseases, human immunodeficiency virus or portal hypertension. Familial cases were already reported in the early fifties and, in 2000, bone morphogenic protein receptor type 2 gene (BMPR2) was identified as the gene responsible for more than 70% of HPAH and about 20% of IPAH. BMPR2 belongs to a superfamily of growth factor receptors, including bone morphogenic protein (BMPs) and transforming growth factor beta (TGF-β) and consequently controls cellular functions such as proliferation, migration, differentiation or apoptosis. BMPR2 mutations may favor activation of p38MAPK-dependent pro-proliferative pathways, which is also ; a key player in cytokine-induced inflammatory signaling pathways. Although BMPR2 mutation carriers develop PAH 10 years earlier than non-carriers and display more severe hemodynamic changes, only 20% of BMPR2 mutation carriers will further develop PAH. A role of inflammation in the pathogenesis of PAH has been suggested. A predictive role of various cytokines has been recently evidenced in PAH. The investigators have observed elevated C-reactive protein (CRP) circulating levels in PAH and evidenced a predictive role of CRP in PAH. Interestingly, heterozygous null BMPR2 mice failed to develop PAH unless an additional inflammatory insult was applied. More recently, inhibition of leukocyte recruitment has been shown to impair PAH progression in mice with genetic ablation of endothelial BMPR-II. This consequently suggests that inflammation could play the role of a second hit in BMPR2 mutation carriers to further develop PAH.

Besides, lipoprotein-associated phospholipase A2 (Lp-PLA2) also named plasma platelet-activating factor-acetylhydrolase (PAF-AH), is the product of PLA2G7 gene and is an enzyme capable of inactivating platelet-activating factor (PAF), a potent lipid mediator of inflammation and a potent vasoconstrictor, and its analogs. Several studies have evidenced an increase in PAF-AH mass and activity in hypercholesterolemia and coronary heart disease. In a recent meta-analysis including more than 70,000 patients from 32 epidemiologic studies, high circulating PAF-AH levels have been identified as an independent predictive risk factor for cardiovascular events. When over-expressed in rodents, Lp-PLA2 displayed anti-inflammatory properties and reduced atherogenesis, suggesting a potential anti-inflammatory role of Lp-PLA2. Lp-PLA2 polymorphisms have been identified and Lp-PLA2 activity has been strongly associated with genetic variants related to LDL- cholesterol levels. In a preliminary study, the investigators have observed a diminished Lp-PLA2 activity in the plasma of PAH patients, together with low total and LDL-cholesterol levels.

HYPOTHESIS \& OBJECTIVES

Regarding previous and current results by the investigators, they hypothesized that combining analysis of different inflammatory biomarkers and BMPR2 mutations, which are currently analyzed in each patient diagnosed with idiopathic or familial PAH, could contribute to establish an earlier diagnosis and consequently better orientate the therapeutic strategy. Moreover, BMPR2 gene mutations are responsible for more than 70% of HPAH and about 20% of IPAH; among human BMPR2 mutation carriers, only 20% will further develop PAH, suggesting that BMPR2 mutation itself is not the unique cause for developing PAH and that a second hit, such as inflammation, would be required and play a triggering role in the development of PAH.

METHODOLOGY

  1. Identification of biomarkers For the current study, one aim is to identify one or several biomarkers which could predict adverse outcome in PAH. To address this aim, the investigators would like to evaluate the levels of CRP, total cholesterol, HDL-cholesterol, triglycerides, albumin, Lp-PLA2 activity, Thrombin Activatable Fibrinolysis Inhibitor (TAFI) and vitamin D in blood plasma from all patients diagnosed with PAH at the UZ Leuven (Campus Gasthuisberg). To perform these analyses, the investigators would need 5 tubes of blood:
  • one on EDTA to be sent to the Hospital Laboratory (CRP, lipid profile and albumin);
  • one on citrate to further measure TAFI (Laboratory of Pharmaceutical Biology, KU Leuven);
  • one on EDTA to prepare plasma to be further stored in the laboratory of Pneumology (KU Leuven), from which an aliquot will be sent to INSERM UMRS937 (Paris, France), to measure Lp-PLA2 activity;
  • one on EDTA is sent to the CME genomic DNA isolation to study BMPR2, ALK-1 and ENG mutations; genomic DNA will be stored for potential future genetic;
  • one with Silica Clot Activator to be sent to the Hospital Laboratory (vitamin D).
  1. Human pulmonary arterial cell isolation Another aim is to investigate whether a relationship between impaired BMPR2 signaling and inflammation could result in dysfunction of pulmonary arterial cells in PAH. To achieve our objective, the investigators propose to investigate:
  2. the in vitro effects of inflammatory mediators and macrophages on the activation of human pre-capillary pulmonary arterial endothelial cell (PAEC) and on the proliferating and migrating properties of PASMC from BMPR2 carriers and non-carriers PAH patients; ii. expression and distribution of inflammatory mediators, their receptors and BMPR2 in human lung parenchyma and distal pulmonary arteries; iii. the ex-vivo vasoreactive effects of inflammatory mediators mentioned above on isolated human pre-capillary pulmonary arteries. iv. Moreover, pulmonary arterial endothelial cells will be harvested from patients undergoing right heart catheterization using a recently described technique, consisting in isolating endothelial cells from the balloon of a Swan-Ganz catheter commonly used to performed right heart catheterization in patients.
  3. Pulmonary tissue collection

Lung parenchyma will be collected from i) PAH patients at the time of lung transplantation, ii) eventually unused donor lungs and iii) tissue surrounding lung tumour resection from patients without COPD. Pulmonary pre-capillary endothelial and smooth muscle cells will be isolated, maintained in culture and further stored at low passage number in liquid nitrogen.

Two pieces of lung parenchyma will be snap frozen for further RNA isolation and protein extraction; one piece will be fixed in paraformaldehyde and further processed for immunohistochemistry analyses.

Keywords
Pulmonary Arterial Hypertension, BMPR2, Inflammation
Medical subject headings
Familial Primary Pulmonary Hypertension, Pulmonary Arterial Hypertension, Inflammation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Circulating Inflammatory Biomarkers: CRP, total cholesterol, HDL-cholesterol, triglycerides, albumin, Lp-PLA2 activity, Thrombin Activatable Fibrinolysis Inhibitor (TAFI), vitamin D

    Measured: Changes from baseline in circulating inflammatory biomarkers will be evaluated at 6 months, 12 months and 24 months whenever a right heart catheterization will be performed after starting a treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02959723
Sponsor's protocol ID
UZL-S57114
Other IDs
S57114
Status last verified
Nov 2016
First submitted
23 Apr 2015
Last updated
9 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Arterial Hypertension, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 9 Nov 2016. 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 Belgium. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circulating Inflammatory Biomarkers: CRP, total cholesterol, HDL-cholesterol, triglycerides, albumin, Lp-PLA2 activity, Thrombin Activatable Fibrinolysis Inhibitor (TAFI), vitamin D (time frame: Changes from baseline in circulating inflammatory biomarkers will be evaluated at 6 months, 12 months and 24 months whenever a right heart catheterization will be performed after starting a treatment). 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 9 Nov 2016.

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