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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
fludeoxyglucose
Sponsored by
Joan Albert Barbera Mir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

  2. 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

  3. 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    FDG

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    FDG uptake in lung parenchyma

    Secondary Outcome Measures

    Full Information

    First Posted
    August 29, 2016
    Last Updated
    September 17, 2019
    Sponsor
    Joan Albert Barbera Mir
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02886793
    Brief Title
    Cell Proliferation in Pulmonary Hypertension. FDG-PET Comparison Between Patients and Healthy Subjects
    Acronym
    PROCLAIM
    Official Title
    Cell Proliferation in Pulmonary Hypertension. FDG-PET Comparison Between Patients and Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    July 2018 (Actual)
    Study Completion Date
    August 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Joan Albert Barbera Mir

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Hypertension

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FDG
    Arm Type
    Experimental
    Arm Description
    all patients will undergo a PET scan and will receive 18F fludeoxyglucose
    Intervention Type
    Drug
    Intervention Name(s)
    fludeoxyglucose
    Other Intervention Name(s)
    FDG
    Primary Outcome Measure Information:
    Title
    FDG uptake in lung parenchyma
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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