A proposal to standardize dyspnoea measurement in clinical trials of acute heart failure syndromes: The need for a uniform approach

Peter S. Pang, John G.F. Cleland, John R. Teerlink, Sean P. Collins, Christopher J. Lindsell, George Sopko, W. Frank Peacock, Gregg C. Fonarow, Amer Z. Aldeen, J. Douglas Kirk, Alan B. Storrow, Miguel Tavares, Alexandre Mebazaa, Edmond Roland, Barry M. Massie, Alan S. Maisel, Michel Komajda, Gerasimos Filippatos, Mihai Gheorghiade

Research output: Contribution to journalReview articlepeer-review

129 Scopus citations

Abstract

Dyspnoea is the most common presenting symptom amongst patients with acute heart failure syndromes (AHFS). It is distressing to patients and therefore an important target for treatment in clinical practice, clinical trials, and for regulatory approval of novel agents. Despite its importance as a treatment target, no consensus exists on how to assess dyspnoea in this setting. There is a considerable uncertainty about the reproducibility of the various instruments used to measure dyspnoea, their ability to reflect changes in symptoms and whether they accurately reflect the patient's experience. Little attempt has been made to ensure consistent implementation with respect to patients' posture during assessment or timing in relationship to therapy. There is also limited understanding of how rapidly and completely dyspnoea responds to standard therapy. A standardized method with which to assess dyspnoea is required for clinical trials of AHFS in order to ensure uniform collection of data on a key endpoint. We propose the Provocative Dyspnoea Assessment, a method of measurement that combines sequential dyspnoea provocation by positioning and walking with a dyspnoea self assessment using a five-point Likert scale, to yield a final Dyspnoea Severity Score. This proposed tool requires detailed validation but has face validity for the uniform assessment of dyspnoea.

Original languageEnglish (US)
Pages (from-to)816-824
Number of pages9
JournalEuropean heart journal
Volume29
Issue number6
DOIs
StatePublished - Mar 2008

Funding

B.M. reported receiving consultation fees from Novacardia, Scios, PDL BioPharma, Cytokinetics and research grants from Novacardia, Bristol Myers Squibb, and Sanofi-Aventis. M.G. reported receiving research grants from the NIH, Otsuka, SigmaTau, Merck, and Scios Inc.; he is or has been a consultant to Debbio Pharm, ErreKappa Terapeutici, GlaxoSmithKline, Medtro-nic, Otsuka, Protein Design Lab, Scios Inc., and SigmaTau.

Keywords

  • Clinical trials
  • Dyspnoea
  • Heart failure

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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