OPTIME—CHF | SURVIVE | VERITAS | EVEREST | PROTECT | ASCEND-HF | RELAX-AHF | REVIVE I | REVIVE II | DOSE | CARRESS | ROSE | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Was dyspnoea an end point? | Secondary | Secondary | Co-primary | Secondary | Primary | Co-primary | Primary | Primary | Secondary | Secondary | Secondary | Secondary | Secondary |
Instrument/scale used to measure dyspnoea | Composite HF score (not validated) | 7-point Likert scale | VAS (quantified by AUC) | 7-point Likert scale | 7-point Likert scale | 7-point Likert scale | VAS (quantified by AUC) | 7-point Likert scale | 7-point Likert scale | 7-point Likert scale | VAS (quantified by AUC) | VAS (quantified by AUC) | VAS (quantified by AUC) |
When was dyspnoea measured? | Baseline, day 3 and discharge | 24 h | Baseline, 3, 6 and 24 h | 24 h | 24 h and daily until discharge | 6 and 24 h | Baseline and days 1–5 | 6, 12 and 24 h | 24, 48 h and days 3 and 5 | 6, 24, 48 h and days 3 and 5 | Baseline to 72 h | Baseline, 96 h and 1 week | 24 h and 48 h |
Criteria for success? | Greater reduction in mean HF score for the active group compared to placebo | Greater % of pts reporting ≥mild improvement in active group compared to placebo | Mean difference of ≥150 mm×h for the active group compared to placebo | Greater % of pts showing improvement in dyspnoea score for active group compared to placebo | Greater % of pts reporting ≥moderate improvement compared to placebo | Greater % of pts reporting ≥moderate improvement compared to placebo | Mean difference of ≥468 mm×h for the active group compared to placebo | Greater % of pts reporting ≥moderate improvement compared to placebo | Greater % of pts reporting improvement in dyspnoea | Greater % of pts reporting Improvement in dyspnoea | |||
Improvement in dyspnoea? | No | No | No | Yes | No | Yes/no* | Yes | No | Yes | Yes | Yes† | No | No |
*Depending on which statistical analysis plan considered.
†High-dose cohort.
CHF, chronic heart failure; HF, heart failure; VAS, visual analogue score.