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End points and clinical trial designs in pulmonary arterial hypertension - Clinical and regulatory perspectives

Hoeper, MM; Oudiz, RJ; Peacock, A; Tapson, VF; Haworth, SG; Frost, AE; Torbicki, A; (2004) End points and clinical trial designs in pulmonary arterial hypertension - Clinical and regulatory perspectives. Journal of the American College of Cardiology , 43 (12) 48S-55S.

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Abstract

To date, randomized controlled clinical trials performed in pulmonary arterial hypertension (PAH) have been relatively short-term studies involving mainly patients with advanced disease. The primary end points in these trials have addressed exercise capacity, usually by using the 6-min walk test. Although this approach is still warranted in future trials assessing new treatments, it is likely that the focus will shift toward trials of longer duration, involving patients with less advanced disease, and that different drugs and drug- combination regimens will be compared. In such trials, it is possible that a composite of markers indicating clinical deterioration (e.g., hospitalization for right heart failure, the requirement for the introduction of an alternative treatment, and predefined indicators of worsening exercise tolerance) may be more useful as primary end points. Quality of life will become a very important issue; however, appropriate quality-of-life questionnaires for PAH have yet to be developed. In addition, hemodynamics will likely remain valuable as secondary end points, but future clinical trials should include hemodynamics obtained both during exercise and at rest. Finally, cardiopulmonary exercise testing, echocardiographic studies, and biochemical parameters, such as brain natriuretic peptide or troponin T, may also prove useful as secondary end points in the future. (C) 2004 by the American College of Cardiology Foundation

Type: Article
Title: End points and clinical trial designs in pulmonary arterial hypertension - Clinical and regulatory perspectives
Additional information: JournalJUN 16S831QIJ AMER COLL CARDIOL
Keywords: 16, 2004, A, AND, ARTERIAL, biochemical, BOTH, BRAIN, Brain Natriuretic Peptide, c, CAPACITY, Cardiology, CLINICAL, clinical trial, Clinical Trials, CLINICAL-TRIAL, COMBINATION, DESIGN, DEVELOPED, DISEASE, DRUG, DRUGS, DURATION, EXERCISE, FAILURE, FOCUS, FOR, FUTURE, HEART, HEMODYNAMICS, Hospitalization, HYPERTENSION, INDICATOR, IS, JOURNAL, LIFE, MARKER, NATRIURETIC PEPTIDE, NEW, OF, OF-LIFE, PATIENT, patients, PEPTIDE, PULMONARY, QUALITY, Quality of Life, QUALITY-OF-LIFE, QUESTIONNAIRE, Questionnaires, randomized, s, secondary, SHIFT, THE, TREATMENT, TRIAL, TRIALS
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Pop Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Pop Health Sciences > UCL GOS Institute of Child Health > ICH Developmental Neurosciences Prog
URI: http://discovery.ucl.ac.uk/id/eprint/181199
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