Serum Bio-markers in Pulmonary Hypertension

NCT04472533 | Completed

• 1 other identifier: T01502
• Study Type: observational
• Target: 377
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by scarred blood clots in the blood vessels supplying the lungs. This in turn leads to failure of the right side of the heart. The reason why these scarred clots form is unknown. An operation to remove the scarred clots, known as pulmonary endarterectomy, is a potential cure. However, some patients have persistent obstructions within the blood vessels and heart failure even after surgery. It is thought that abnormal levels of proteins, found in the blood stream and responsible for inflammation and the development of new blood vessels may have role in causing the disease. In this study, these proteins were measured to assess whether they provide clues as to the cause of the disease and whether they could be used for the risk stratification of patients.

Conditions

Pulmonary Hypertension, Primary, 4

Keywords

inflammation; angiogenesis

Outcome Measures

Primary Outcomes (1)

• Assess the differences between circulating biomarkers between patients with CTEPH, CTED and controls

  Assess differences in inflammatory cytokines (IL6, 8, 10, TNFa, hsCRP \[all measured in pg/ml\]) and markers of angiogenesis (Ang2, BMP9, Endoglin, VEGFa, VEGFc, VEGFd \[all measured in pg/ml\]) in patients with CTEPH compared to healthy controls

  24 hours

Secondary Outcomes (11)

• Assess associations, using multivariate regression modelling, between IL6 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH

  24 hours

• Assess associations, using multivariate regression modelling, between IL8 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH

  24 hours

• Assess associations, using multivariate regression modelling, between IL10 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH

  24 hours

• Assess associations, using multivariate regression modelling, between TNFa and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH

  24 hours

• Assess associations, using multivariate regression modelling, between Ang2 and clinical assessments made prior to pulmonary endarterectomy in patients with CTEPH

  24 hours

Study Arms (3)

CTEPH

Patients diagnosed with chronic thromboembolic pulmonary hypertension

CTED

Patients diagnosed with chronic thromboembolic disease but no evidence of pulmonary hypertension

Control

Healthy control subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with CTEPH, CTED and healthy control volunteers at the Royal Papworth Hospital.

You may qualify if:

• Patients able to give informed written consent
• Patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) according to international guidelines at an expert pulmonary hypertension centre
• Patients diagnosed with chronic thromboembolic disease (CTED) according to international guidelines at an expert pulmonary hypertension centre
• Age and sex matched healthy volunteers

You may not qualify if:

• Patients with inflammatory comorbidities
• Patients taking immunosuppressant medication

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, CB2 0AY, United Kingdom

Location

Related Publications (1)

• Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.

  PMID: 26320113 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary; Inflammation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joanna Pepke-Zaba, PhD FRCP

  Royal Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 15, 2020
• Study Start: April 4, 2012
• Primary Completion: August 31, 2017
• Study Completion: October 26, 2017
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)