PET/MRI in PAH Patients

Pulmonary Arterial Hypertension Clinical Trial

Official title:

The Relationship Between Myocardial 18F-FDG Uptake and Right Ventricular Coupling Obtained by PET/MRI Hybrid Imaging in Patients With Pulmonary Arterial Hypertension.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03688698
• Other study ID #: 2017/25/N/NZ5/02689
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: January 1, 2018

Study information

• Verified date: September 2018
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Aim of the study is to compare novel parameters of right ventricle (RV) function from right heart catheterization (RHC) and magnetic resonance imaging (MRI) with PET-derived RV FDG uptake.

Description:

Objectives In pilot study investigators aimed to compare novel parameters of right ventricle (RV) function from right heart catheterization (RHC) and magnetic resonance imaging (MRI) with PET-derived RV FDG uptake.

Background Right ventricular (RV) function is a major determinant of survival in patients with pulmonary arterial hypertension (PAH). Hemodynamic parameters like end-systolic elastance (Ees), arterial elastance (Ea), pulmonary arterial compliance (PAC) and Ees/Ea ratio have been shown to reflect RV function and prognosis in PAH. Increased RV 18F-fluoro-2-deoxyglucose (FDG) uptake in positron emission tomography (PET) was recently associated with progressive RV dysfunction in these patients.

Methods Twenty-five stable PAH patients (49.92±15.94 years) and twelve healthy subjects (control group, 44.75±13.51 years) had simultaneous PET and MRI scans performed. FDG was used as a tracer and its uptake was presented as a standardized uptake value (SUV) for both left (LV) and right ventricle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 1, 2018
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• PAH

Exclusion Criteria:

The exclusion criteria were the following: patients in IV WHO class, Eisenmenger physiology, PAH associated with prevalent systemic-to-pulmonary shunts due to moderate to large defects (according to European guidelines) [16], group II, III, IV, V of pulmonary hypertension, diabetes mellitus and contraindications to cardiac MRI.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Radiation:
• PET/MRI
PET/MRI scans

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in PET/MRI parameters in PAH Patients after 2 years follow-up in case of death or clinical deterioration	We would like to depict most significant changes in newly approved parameters from hybrid PET/MRI imaging e.g. standardised uptake value of glucose in heart, right ventricle ejection fraction, end systolic elastance, mean pulmonary pressure. This could allow us indicate possible new prognostic factors in PAH.	2 years
Secondary	Need of PAH targeted therapy escalation	Clinical worsening of patient leading to therapy escalation.	2 years