Lack of correlation between levels of BNP and responses on a visual analog scale in decompensated heart failure: potential implications for clinical trial design

2004 ◽  
Vol 10 (4) ◽  
pp. S105
Author(s):  
Bruce Czarnik ◽  
Brian C. Taschner ◽  
Steven C. Kuehn ◽  
Robert E. Wolf ◽  
Paul J. Hauptman
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Visual Analog Scale ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Decompensated Heart Failure ◽  
Analog Scale

scholarly journals Measuring the Dyspnea of Decompensated Heart Failure With a Visual Analog Scale: How Much Improvement Is Meaningful?

2004 ◽  
Vol 10 (4) ◽  
pp. 188-191 ◽  
Author(s):  
Douglas S. Ander ◽  
Imoigele P. Aisiku ◽  
Jonathan J. Ratcliff ◽  
Knox H. Todd ◽  
Karen Gotsch
Keyword(s):  
Heart Failure ◽  
Visual Analog Scale ◽  
Decompensated Heart Failure ◽  
Analog Scale

scholarly journals Clinical Trial Design, Endpoints and Regulatory Considerations in Heart Failure

2019 ◽  
Vol 17 ◽  
Author(s):  
Giuseppe Rosano
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Functional Capacity ◽  
Trial Design ◽  
Clinical Trial Design ◽  
New Drugs ◽  
Regulatory Agencies ◽  
Mortality And Morbidity ◽  
Increased Risk ◽  
New Treatments

After the withdrawal of flosequinan in the early 1990’s, because of an increased risk of mortality and fatal arrhythmias, the bar for the approval of new drugs in heart failure has been raised and regulatory agencies have requested evidence for the efficacy of new treatments on mortality and morbidity end-points. However, more recently, regulatory agencies have become more open to include the assessment of functional capacity as an efficacy endpoint, at least in selected subgroups of patients. Therefore, a new therapy for the treatment of heart failure can be approved if it improves survival and/or reduces hospitalisations or if it safely improves functional capacity. This article reviews clinical trial design, trial endpoints and regulatory issues in Heart Failure trials.

scholarly journals Comorbidities and cause-specific outcomes in heart failure across the ejection fraction spectrum: A blueprint for clinical trial design

2020 ◽  
Vol 313 ◽  
pp. 76-82 ◽  
Author(s):  
Gianluigi Savarese ◽  
Camilla Settergren ◽  
Benedikt Schrage ◽  
Tonje Thorvaldsen ◽  
Ida Löfman ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Ejection Fraction ◽  
Trial Design ◽  
Clinical Trial Design
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