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

Sponsor
Joan Albert Barbera Mir (Other)
Overall Status
Completed
CT.gov ID
NCT02886793
Collaborator
(none)
65
Enrollment
1
Arm
26
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Cell Proliferation in Pulmonary Hypertension. FDG-PET Comparison Between Patients and Healthy Subjects
Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Jul 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: FDG

all patients will undergo a PET scan and will receive 18F fludeoxyglucose

Drug: fludeoxyglucose
Other Names:
  • FDG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. FDG uptake in lung parenchyma [1 hour]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Patients with PAH:

    • Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg

    • Exclusion of group 2,3,4 or 5

    1. 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

    1. 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Joan Albert Barbera Mir

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joan Albert Barbera Mir, Dr, Hospital Clinic of Barcelona
    ClinicalTrials.gov Identifier:
    NCT02886793
    Other Study ID Numbers:
    • 2016-000347-14
    First Posted:
    Sep 1, 2016
    Last Update Posted:
    Sep 18, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hypertension, Pulmonary
    Hypertension

    Study Results

    No Results Posted as of Sep 18, 2019