Heart failure & cardiomyopathiesRandomised controlled trial
Balcinrenone Plus Dapagliflozin in Patients with Heart Failure and Chronic Kidney Disease: Results from the Phase 2b MIRACLE Trial
- Randomised controlled trial
- phase 2b
- placebo-controlled
- stopped early (slow recruitment)
Authors' conclusion
While the smaller than planned sample size limits interpretation, we did not see significant reduction in UACR in patients treated with balcinrenone plus dapagliflozin compared with dapagliflozin plus placebo.
Study context
- Population
- Adults with symptomatic heart failure (HF), EF <60%, estimated glomerular filtration rate (eGFR) ≥30 to ≤60 ml/min/1.73 m² and urinary albumin-to-creatinine ratio (UACR) ≥30 to <3000 mg/g
- Participants
- 133 adults
- Comparison
- Balcinrenone 15, 50 or 150 mg/day plus dapagliflozin vs dapagliflozin plus placebo
- Primary endpoint
- Relative reduction in UACR from baseline
- Follow-up
- Week 12
Primary result
As reported in the abstract
Relative reduction in UACR
- Not significantly different between balcinrenone plus dapagliflozin groups vs dapagliflozin plus placebo
- No clear balcinrenone dose-response relationship
- enrolment stopped early because of slow recruitment
Further findings
NT-proBNP
- Non-significant trends towards reduced levels
Safety
| Outcome | Balcinrenone 15 mg + dapagliflozin | Balcinrenone 50 mg + dapagliflozin | Balcinrenone 150 mg + dapagliflozin | Dapagliflozin + placebo |
|---|---|---|---|---|
| Hyperkalaemia adverse events leading to discontinuation | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract | 0 events |
- Hyperkalaemia adverse events leading to discontinuation: Balcinrenone + dapagliflozin 2 events
Hyperkalaemia adverse events leading to discontinuation
- Possible dose-dependent increases in serum potassium; reduced eGFR in the highest dose group
Original publication
Balcinrenone Plus Dapagliflozin in Patients with Heart Failure and Chronic Kidney Disease: Results from the Phase 2b MIRACLE Trial. Eur J Heart Fail. Published 23 May 2024. doi:10.1002/ejhf.3294
Summarised from the published abstract; every number is checked against it