PET/MRI in PAH Patients

NCT03688698 | Completed

• 1 other identifier: 2017/25/N/NZ5/02689
• Study Type: observational
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

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.

  2 years

Secondary Outcomes (1)

• Need of PAH targeted therapy escalation

  2 years

Study Arms (2)

PAH

Radiation: PET/MRI

Controls

Radiation: PET/MRI

Interventions

PET/MRI RADIATION

PET/MRI scans

Controls; PAH

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- PAH

Sponsors & Collaborators

• Medical University of Bialystok: lead

Related Publications (2)

• Kazimierczyk R, Szumowski P, Nekolla SG, Malek LA, Blaszczak P, Hladunski M, Sobkowicz B, Mysliwiec J, Kaminski KA. The impact of specific pulmonary arterial hypertension therapy on cardiac fluorodeoxyglucose distribution in PET/MRI hybrid imaging-follow-up study. EJNMMI Res. 2023 Mar 9;13(1):20. doi: 10.1186/s13550-023-00971-w.

  PMID: 36892707 DERIVED

• 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.

  PMID: 33966635 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Student

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: September 28, 2018
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: January 1, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share