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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Drug: fludeoxyglucose

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FDG; all patients will undergo a PET scan and will receive 18F fludeoxyglucose	Drug: fludeoxyglucose; Other Names: FDG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FDG uptake in lung parenchyma	1 hour

Collaborators and Investigators

• Sponsor: Joan Albert Barbera Mir

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 2016-000347-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No