Cardio-oncology & otherRandomised controlled trial
Sacubitril/Valsartan and Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy: The PRADA II Randomized Clinical Trial
- Randomised controlled trial
- parallel-group
- placebo-controlled
- double-blind
- multicentre
- 4 academic medical centres in Norway
Authors' conclusion
Anthracycline-based treatment for early breast cancer was associated with a reduction in left ventricular ejection fraction that was not significantly attenuated by sacubitril/valsartan.
Study context
- Population
- Women receiving anthracycline-containing adjuvant therapy for early breast cancer
- Participants
- 138 women
- Comparison
- Sacubitril/valsartan vs placebo
- Primary endpoint
- Change in left ventricular ejection fraction by cardiovascular magnetic resonance
- Follow-up
- From prior to initiation of chemotherapy to 18 months thereafter
Primary result
As reported in the abstract
Change in LVEF by cardiovascular magnetic resonance · baseline to 18 months
- Between-group difference in LVEF decline: 1.1 percentage points (95% CI, −0.4 to 2.7)
- P = 0.16
Secondary outcomes
| Outcome | log difference (95% CI) | |
|---|---|---|
| NT-proBNP and cardiac troponin I increase · baseline to 18 months · NT-proBNP · greater mean increases with placebo | 0.3 (0.05–0.6) | |
| NT-proBNP and cardiac troponin I increase · baseline to 18 months · cardiac troponin I · greater mean increases with placebo | 0.5 (0.1to 1.0) | |
| −0.500.511.5Difference (linear scale) |
Change
| Outcome | Sacubitril/valsartan | Placebo | Estimate |
|---|---|---|---|
| LV global longitudinal strain (echocardiographic) · baseline to 18 months | −0.3 (95% CI −0.80–0.2) | 0.5 (95% CI 0.05–1.0) |
- LV global longitudinal strain (echocardiographic): normal and stable with sacubitril/valsartan; progressive decline with placebo
LV global longitudinal strain (echocardiographic) · baseline to 18 months
- Between-group difference in GLS change: −0.9 (95% CI, −1.5 to −0.2)
Original publication
Sacubitril/Valsartan and Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy: The PRADA II Randomized Clinical Trial. Circulation. Published 29 August 2025. doi:10.1161/circulationaha.125.076616
Summarised from the published abstract; every number is checked against it