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

NCT02886793 | Completed Phase 1

• 1 other identifier: 2016-000347-14
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• FDG uptake in lung parenchyma

  1 hour

Study Arms (1)

FDG

EXPERIMENTAL

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

Drug: fludeoxyglucose

Interventions

fludeoxyglucose DRUG

Also known as: FDG

FDG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joan Albert Barbera Mir: lead

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share