Table 3

Comparison of dyspnoea assessment

OPTIME—CHFSURVIVEVERITASEVERESTPROTECTASCEND-HFRELAX-AHFREVIVE IREVIVE IIDOSECARRESSROSE
Was dyspnoea an end point?SecondarySecondaryCo-primarySecondaryPrimaryCo-primaryPrimaryPrimarySecondarySecondarySecondarySecondarySecondary
Instrument/scale used to measure dyspnoeaComposite HF score (not validated)7-point Likert scaleVAS (quantified by AUC)7-point Likert scale7-point Likert scale7-point Likert scaleVAS (quantified by AUC)7-point Likert scale7-point Likert scale7-point Likert scaleVAS (quantified by AUC)VAS (quantified by AUC)VAS (quantified by AUC)
When was dyspnoea measured?Baseline, day 3 and discharge24 hBaseline, 3, 6 and 24 h24 h24 h and daily until discharge6 and 24 hBaseline and days 1–56, 12 and 24 h24, 48 h and days 3 and 56, 24, 48 h and days 3 and 5Baseline to 72 hBaseline, 96 h and 1 week24 h and 48 h
Criteria for success?Greater reduction in mean HF score for the active group compared to placeboGreater % of pts reporting ≥mild improvement in active group compared to placeboMean difference of ≥150 mm×h for the active group compared to placeboGreater % of pts showing improvement in dyspnoea score for active group compared to placeboGreater % of pts reporting ≥moderate improvement compared to placeboGreater % of pts reporting ≥moderate improvement compared to placeboMean difference of ≥468 mm×h for the active group compared to placeboGreater % of pts reporting ≥moderate improvement compared to placeboGreater % of pts reporting improvement in dyspnoeaGreater % of pts reporting
Improvement in dyspnoea
Improvement in dyspnoea?NoNoNoYesNoYes/no*YesNoYesYesYes†NoNo
  • *Depending on which statistical analysis plan considered.

  • †High-dose cohort.

  • CHF, chronic heart failure; HF, heart failure; VAS, visual analogue score.