Heart failure & cardiomyopathiesRandomised controlled trial
Estimating the Placebo Effect on Patient-Reported Outcomes in Sham-Controlled Device Trials: Insights From REDUCE LAP-HF II
- randomized participants to atrial shunt or sham procedure
- sham-controlled
- unblinding after 2 years
Authors' conclusion
In a sham-controlled device trial that collected patient-reported outcome data during blinded allocation to treatment or sham and after unblinding, the estimated mean placebo effect benefit and loss on the KCCQ-OS were small (≤2 points). Finding a modest placebo effect on patient-reported outcomes may increase confidence in their use as clinical trial outcomes.
Study context
- Population
- Participants of REDUCE LAP-HF II (heart failure) randomized to atrial shunt or sham procedureanalytic cohort (median age, 72 years, 65.6% female) · sham-treated 182 · shunt-treated 239
- Participants
- 421 participants
- Comparison
- Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) changes before and after unblinding in sham-treated and shunt-treated patients
- shamn = 182
- shuntn = 239
Primary result
As reported in the abstract
KCCQ-OS change from baseline to 2 years (placebo effect plus other benefits from trial participation) · 2 years
sham
+9.3
mean improvement · SD 22.4 · points
shunt
+12.7
mean improvement · SD 22.8 · points
Further findings
Mean change, points
| Outcome | sham | shunt |
|---|---|---|
| KCCQ-OS change from 2 to 3 years after unblinding (placebo effect loss in sham; placebo effect benefit in shunt) | −1.7 (SD 18.2) | +1.9 (SD 18.2) |
Combined placebo effects in a hypothetical unblinded trial
- combined effects
- 3.6 points
- hypothetical unblinded trial where placebo effect benefit would be expected in the active intervention arm, and none in the untreated arm
Original publication
Estimating the Placebo Effect on Patient-Reported Outcomes in Sham-Controlled Device Trials: Insights From REDUCE LAP-HF II. Circ Popul Health Outcomes. Published 12 January 2026. doi:10.1161/circoutcomes.125.012676
Summarised from the published abstract; every number is checked against it