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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02886793

Acronym

PROCLAIM

Enrollment

Registered

2016-09-01

Start date

2016-06-30

Completion date

2018-08-31

Last updated

2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

DRUGfludeoxyglucose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
FDG uptake in lung parenchyma	1 hour

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026