BARACK-D Trial: Low-Dose Spironolactone and Cardiovascular Outcomes in Moderate Stage Chronic Kidney Disease
The BARACK-D trial is a prospective, randomized, open, blinded endpoint study that investigates the effects of low-dose spironolactone in patients with stage 3b chronic kidney disease (CKD) and assesses its impact on cardiovascular (CV) outcomes.
Objective:
The primary goal of the trial is to determine the impact of aldosterone receptor antagonists (ARAs), specifically spironolactone, on renal and cardiovascular outcomes in patients with moderate stage CKD (stage 3b).
Study Population:
- Total Patients: 1,372
- Inclusion Criteria:
- Patients aged 18 years or older, diagnosed with CKD stage 3b.
- Two or more recent eGFR blood tests in primary care records at least 6 weeks apart, or one test in the past 24 months requiring a second confirmatory test.
- The confirmatory eGFR test was performed at least 6 weeks after the initial test.
Study Groups:
- Spironolactone Group: 677 patients were randomized to receive low-dose spironolactone.
- Usual Care Group: 695 patients continued with their usual care regimen without spironolactone.
Primary Outcome:
The primary outcome was time from randomization until the first occurrence of:
- Death
- Hospitalization for heart disease
- Stroke
- Heart failure
- Transient ischemic attack (TIA)
- Peripheral arterial disease
- First onset of any listed condition not present at baseline
Outcome Rates:
- Spironolactone Group: 16.7%
- Usual Care Group: 16.0%
- Hazard Ratio (HR): 1.05, 95% CI: 0.81–1.37
Conclusion:
Among patients with stage 3b CKD, treatment with low-dose spironolactone did not result in a significant reduction in mortality or cardiovascular events compared to usual care. Moreover, there was no meaningful benefit in terms of CV outcomes, and more participants in the spironolactone group discontinued the study due to safety concerns.
Reference: Hobbs, F.D.R et al. Nat Med. 2024. https://doi.org/10.1038/s41591-024-03263-5.