Clinical trial NCT03688698: PET/MRI in PAH Patients
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We enrolled twenty-five stable adult patients diagnosed with pulmonary arterial hypertension. A diagnosis of pre-capillary pulmonary hypertension (PH) was confirmed by right heart catheterization \[mean pulmonary artery pressure (mPAP) ≥25 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg\] and the use of an algorithm that included perfusion lung scan, echocardiography, respiratory function tests, and computer tomography to rule out secondary PH causes according to European guidelines \[16\]. The control group consisted of twelve healthy controls who were matched based on sex and age. During the baseline evaluation, we performed a physical examination, six-minute walk test, laboratory tests e.g. serum B-type natriuretic peptide (BNP), morphology and renal function parameters.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in PET/MRI parameters in PAH Patients after 2 years follow-up in case of death or clinical deterioration
timeFrame: 2 years
Secondary outcomes:
measure: Need of PAH targeted therapy escalation
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Kazimierczyk R, Malek LA, Szumowski P, Nekolla SG, Blaszczak P, Jurgilewicz D, Hladunski M, Sobkowicz B, Mysliwiec J, Grzywna R, Musial WJ, Kaminski KA. Multimodal assessment of right ventricle overload-metabolic and clinical consequences in pulmonary arterial hypertension. J Cardiovasc Magn Reson. 2021 May 10;23(1):49. doi: 10.1186/s12968-021-00743-2.