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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02886793
Recruitment Status : Active, not recruiting
First Posted : September 1, 2016
Last Update Posted : August 3, 2018
Information provided by (Responsible Party):
Joan Albert Barbera Mir, Hospital Clinic of Barcelona

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
Pulmonary Hypertension Drug: fludeoxyglucose Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
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 : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FDG
all patients will undergo a PET scan and will receive 18F fludeoxyglucose
Drug: fludeoxyglucose
Other Name: FDG

Primary Outcome Measures :
  1. FDG uptake in lung parenchyma [ Time Frame: 1 hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
  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

Responsible Party: Joan Albert Barbera Mir, Dr, Hospital Clinic of Barcelona Identifier: NCT02886793     History of Changes
Other Study ID Numbers: 2016-000347-14
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases