ISSN 1016-5169 | E-ISSN 1308-4488
Archives of the Turkish Society of Cardiology
New trial designs and potential therapies for pulmonary artery hypertension [Turk Kardiyol Dern Ars]
Turk Kardiyol Dern Ars. 2014; 42(1): 106-118

New trial designs and potential therapies for pulmonary artery hypertension

Mardi Gomberg-maitland1, Todd M. Bull2, Rajeev Saggar3, Robyn J. Barst4, Amany Elgazayerly5, Thomas R. Fleming6, Friedrich Grimminger7, Maurizio Rainisio8, Duncan J. Stewart9, Norman Stockbridge10, Carlo Ventura11, Ardeschir H. Ghofrani7, Lewis J. Rubin12
1University of Chicago, Department of Medicine, Department of Cardiology, Chicago, Illinois, USA
2University of Colorado, Department of Pulmonary and Critical Care, Department of Medicine, Aurora, Colorado, USA
3Heart and Lung Institute, Phoenix, Arizona, USA
4Columbia University, New York, New York, USA
5European Medicine Agency, London, England
6Washington University, Department of Biostatistics, Seattle, Washington, USA
7Giessen University Hospital, Department of Pulmonary Medicine, Department of Medical Oncology Department, Giessen, Germany
8AbaNovus, SanRemo, Italy
9Ottawa Hospital Research Institute, Department of Cardiology, Department of Medicine, Ottawa, Ontario, Canada
10Food and Drug Administration, White Oak, Maryland, USA
11University of Bologna, Department of Cardiology, Department of Medicine, Bologna, Italy
12University of California, San Diego, Department of Pulmonary and Critical Care Medicine Department, San Diego, California, USA

A greater understanding of the epidemiology, pathogenesis, and pathophysiology of pulmonary artery hypertension (PAH) has led to significant advances, but the disease remains fatal. Treatment options are neither universally available nor always effective, underscoring the need for development of novel therapies and therapeutic strategies. Clinical trials to date have provided evidence of efficacy, but were limited in evaluating the scope and duration of treatment effects. Numerous potential targets in varied stages of drug development exist, in addition to novel uses of familiar therapies. The pursuit of gene and cell-based therapy continues, and device use to help acute deterioration and chronic management is emerging. This rapid surge of drug development has led to multicenter pivotal clinical trials and has resulted in novel ethical and global clinical trial concerns. This paper will provide an overview of the opportunities and challenges that await the development of novel treatments for PAH. (J Am Coll Cardiol 2013;62: D82–91) ©2013 by the American College of Cardiology Foundation.

Keywords: Ethics, pulmonary arterial hypertension, therapeutics, trial designs

How to cite this article
Mardi Gomberg-maitland, Todd M. Bull, Rajeev Saggar, Robyn J. Barst, Amany Elgazayerly, Thomas R. Fleming, Friedrich Grimminger, Maurizio Rainisio, Duncan J. Stewart, Norman Stockbridge, Carlo Ventura, Ardeschir H. Ghofrani, Lewis J. Rubin. New trial designs and potential therapies for pulmonary artery hypertension. Turk Kardiyol Dern Ars. 2014; 42(1): 106-118

Corresponding Author: Mardi Gomberg-maitland, United States
Manuscript Language: Turkish


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