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
About this trial
This is an interventional diagnostic trial for Pulmonary Hypertension
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
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
NCT ID
NCT02886793
First Posted
August 29, 2016
Last Updated
September 17, 2019
Sponsor
Joan Albert Barbera Mir
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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