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

Pulmonary Hypertension Clinical Trial

— PROCLAIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886793
• Other study ID #: 2016-000347-14
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2016
• Est. completion date: August 2018

Study information

• Verified date: September 2019
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• fludeoxyglucose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Joan Albert Barbera Mir

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FDG uptake in lung parenchyma		1 hour