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Design of the exercise MRI evaluation of HIV-pulmonary arterial hypertension longitudinal determinants (EXALTED) trial

Alaiti, Mohamad Amera; Goud, Adityab; Ramani, Gautamb; Bagchi, Sashwateec; Al-Kindi, Sadeera; Sawicki, Stevena; Longenecker, Christophera; Jenkins, Trevora; Pauza, Davidc; Park, Myungd; McComsey, Gracee; Simonetti, Orlandof; Hoit, Briana; Rajagopalan, Sanjaya,b

Journal of Cardiovascular Medicine: November 2017 - Volume 18 - Issue 11 - p 888–896
doi: 10.2459/JCM.0000000000000575
Research articles: Trial designs

Background: Pulmonary arterial hypertension (PAH) is a potentially serious cause of dyspnea and exercise limitation in patients with HIV infection. In this trial, we propose using exercise MRI in conjunction with cardiopulmonary testing to delineate PAH from other causes of cardiovascular dysfunction, identify individuals with exercise-induced PAH who are at high risk of developing resting PAH, and provide longitudinal estimates of progression of PAH and right ventricular function.

Methods: In this prospective observational study, HIV patients with dyspnea and exercise limitation in the absence of identifiable causes and those who meet the inclusion criteria will be enrolled based on resting pulmonary artery pressure (≤ or >40 mmHg) on a screening echocardiogram and exercise limitation on the Modified Medical Research Council dyspnea scale. Patients without evidence of resting PAH will be enrolled into both rest and exercise MRI and cardiopulmonary testing protocol, whereas patients with evidence of PAH on resting echocardiograms will undergo only resting cardiac MRI studies to evaluate right ventricular function and fibrosis. Both patient subgroups will be followed for 24 months to obtain longitudinal progression of the disease. In a sub-study, we will further analyze inflammatory variables that may predict these changes, thus allowing early identification of these patients.

Implications and conclusions: This trial will be the first study to provide an understanding of the mechanisms underpinning the functional deterioration of the right ventricle in patients with HIV and will impart insight into the immune mediators of PAH progression and right ventricular functional deterioration in patients with HIV-PAH.

aDivision of Cardiovascular Medicine, Harrington Heart and Vascular Institute, University Hospitals, Cleveland, Ohio

bDivision of Cardiovascular Medicine, University of Maryland Baltimore, Maryland

cDivision of Infectious Diseases and Institute of Human Virology

dHouston Methodist DeBakey Heart & Vascular Center, Houston, Texas

eDivision of Infectious Disease, Cleveland Medical Center, Cleveland, Ohio

fThe Ohio State University, Columbus, Ohio, USA

Correspondence to Sanjay Rajagopalan, MD, Harrington Heart and Vascular Institute, University Hospitals, Cleveland Medical Center, Case Western Reserve School of Medicine, 11100 Euclid Avenue, Lakeside 3001B, Cleveland, OH 44106, USA Tel: +1 216 844 5450; fax: +1 216 844 8318; e-mail: sanjay.rajagopalan@uhhospitals.org; sanjay.rajagopalan@case.edu

Received 16 March, 2017

Revised 25 June, 2017

Accepted 30 August, 2017

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© 2017 Italian Federation of Cardiology. All rights reserved.