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CompletedNCT03688698Updated Sep 28, 2018

PET/MRI in PAH Patients

An observational study in Pulmonary Arterial Hypertension, sponsored by Medical University of Bialystok. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-28.

Sponsored by Medical University of Bialystok · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
37
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 37 is below the median of 100 across 197 observational studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Medical University of Bialystok is the lead sponsor of 68 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • PAH

Exclusion criteria

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.

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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
37 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • PAH

    Radiation: PET/MRI

  • Controls

    Radiation: PET/MRI

Interventions

  • RadiationPET/MRI

    PET/MRI scans

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. Need of PAH targeted therapy escalation

    Clinical worsening of patient leading to therapy escalation.

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 33966635 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03688698
Lead sponsor
Medical University of Bialystok
Responsible party
Remigiusz Kazimierczyk (MD, PhD Student, Medical University of Bialystok) — Principal investigator
First posted
Sep 28, 2018
Start date
May 1, 2016
Primary completion
Jun 1, 2017
Completion
Jan 1, 2018
Last update
Sep 28, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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