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OpenTrials
Completed

NCT Number: NCT02886793

Cell Proliferation in Pulmonary Hypertension. FDG-PET Comparison Between Patients and Healthy Subjects

Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are serious diseases with poor prognosis despite recent advances. Currently, pulmonary hypertension (PH) is considered a cell proliferative disorder, which has not been adequately characterized due to the lack of markers. A better understanding of the mechanisms that regulate this proliferative disorder will allow the identification of new therapeutic targets for HP.

The objective of the project is to identify cell proliferative processes in severe forms of PH. Patients with PAH (n=20), CTEPH (n=20) and healthy controls (n=20) will undergo characterization of microRNAs (miRNAs) contained within circulating microparticles (MPs) analysis and mitochondrial functionality and FDG-PET to compare cell metabolism in the lungs and the right ventricle between patients and controls.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with PAH:
  • Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
  • Exclusion of group 2,3,4 or 5
  • Patients with CTEPH:
  • Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
  • Persistence of thrombotic perfusion defects on pulmonary scintigraphy or angioCT, after 3 months or more of correct anticoagulant therapy
  • Healthy subjects
  • No known disease or condition
  • Normal lung function, chest x-ray, EKG and blood chemistry and haematology

Exclusion criteria

  • Severe comorbidity.
  • Pulmonary, pleural or rib cage disease interfering with FDG-PET acquisition
  • Malignancy with exception of basocellular carcinoma
  • Current smoker or former smoker (last 10 years or more than 10-year-pack).
  • Pregnant or lactating women Hyperglycemia (fasting above 200 mg/dL)
  • Hypersensitivity to the product or its excipients

Treatment and study plan

fludeoxyglucose

Drug

Other names: FDG

Primary outcomes

  1. FDG uptake in lung parenchyma

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

Joan Albert Barbera Mir

Other

Registry information

Acronym: PROCLAIM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2016
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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