Exploring the use of venous blood samples for diagnosis and monitoring of patients with pulmonary hypertension, and determining the genetic base of disease.

Exploring the use of venous blood samples for diagnosis and monitoring of patients with pulmonary hypertension, and determining the genetic base of disease. - Venous blood sampling in pulmonary hypertension

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55700

Enrollment

1600

Registered

2015-09-23

Start date

2015-10-11

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

elevated lung pressure Pulmonary Hypertension

Interventions

None listed

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with (suspected) PH who are diagnosed with PH and/or undergo diagnostic right heart catheterization in our clinic are eligible for our study. PH is diagnosed conform ESC/ERS guidelines. We include treated and untreated patients. In addition we aim to include an age and gender matched control population containing persons with a normal hemodynamic profile. For this we'll ask volunteers as well as patient suspected of heart disease but with hemodynamic profile and partners, friends and/or family members accompanying the patient in the clinic. Our goal is to form an age matched population.

Exclusion criteria

Exclusion criteria: Not applicable. Control persons with co-morbidities can serve as a control for patients with significant co-morbidity.

Design outcomes

Primary

Measure	Time frame
The main objective of the study is to explore the use of peripheral blood to yield biomarkers for diagnostic and monitoring purposes in PH. For this we will use platelets and plasma, PBMCs, and ECFCs. Secondary objectives of this study are:	—

Secondary

Measure	Time frame
1. To determine whether disease specific expression patterns of nucleic acids in plasma and platelets can be used to identify the presence of (subtypes of) pulmonary hypertension. 2. To determine unknown genetic determinants of pulmonary hypertension. This part of the study is performed in collaboration with the University of Cambridge. PBMCs are used for new generation sequencing techniques (combination of whole genome sequencing and exome sequencing). Patient consent for this part of the project will be requested separately. 3. To characterize key phenotypic abnormalities of endothelial dysfunction in ECFCs from patients with PH regarding reaction to un-physiological high flow, apoptosis, proliferation rate and protein expression. To determine whether ECFCs can be used as reliable alternatives for MVECs, direct comparison of ECFCs and MVECs will be made when paired samples are available. 4. To explore whether some of the established abnormal behavioural aspects of ECFCs are already present in unaffected carriers of disease causing genes, thereby suggesting that they play a direct role in the generation of disease.	—

Measure

Time frame

1. To determine whether disease specific expression patterns of nucleic acids in plasma and platelets can be used to identify the presence of (subtypes of) pulmonary hypertension. 2. To determine unknown genetic determinants of pulmonary hypertension. This part of the study is performed in collaboration with the University of Cambridge. PBMCs are used for new generation sequencing techniques (combination of whole genome sequencing and exome sequencing). Patient consent for this part of the project will be requested separately. 3. To characterize key phenotypic abnormalities of endothelial dysfunction in ECFCs from patients with PH regarding reaction to un-physiological high flow, apoptosis, proliferation rate and protein expression. To determine whether ECFCs can be used as reliable alternatives for MVECs, direct comparison of ECFCs and MVECs will be made when paired samples are available. 4. To explore whether some of the established abnormal behavioural aspects of ECFCs are already present in unaffected carriers of disease causing genes, thereby suggesting that they play a direct role in the generation of disease.

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Countries

Netherlands

Outcome results