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

NCT ID: NCT02886793

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FDG

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

Group Type: EXPERIMENTAL

fludeoxyglucose

Intervention Type: DRUG

Interventions

fludeoxyglucose

Intervention Type: DRUG

Other Intervention Names

FDG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Joan Albert Barbera Mir

OTHER

Sponsor Role: lead

Responsible Party

Joan Albert Barbera Mir

Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2016-000347-14

Identifier Type: -

Identifier Source: org_study_id