The DIAMOND trial is designed to evaluate whether patiromer compared to placebo improves serum potassium control in approximately 820 patients with HFrEF and hyperkalemia.
RCT (n=820)
Double-blind
1:1
Does patiromer improve serum K+ control in patients with HFrEF and hyperkalaemia receiving RAASi therapy?
The DIAMOND trial is designed to evaluate whether patiromer can improve potassium control and enable optimal RAASi therapy in HFrEF patients with hyperkalaemia.
Aims In patients with current or a history of hyperkalaemia, treatment with renin–angiotensin–aldosterone system inhibitors (RAASi) is often compromised. Patiromer, a novel potassium (K + ) binder, may improve serum K + levels and adherence to RAASi. Methods The DIAMOND trial will enroll ∼820 patients with heart failure with reduced ejection fraction (HFrEF; ejection fraction ≤40%). Patients meeting the screening criteria will enter a single‐blinded run‐in phase where they will be started or continued on a mineralocorticoid receptor antagonist (MRA) titrated to 50 mg/day and other RAASi therapy to ≥50% target dose, and patiromer. Patiromer will be titrated up to a maximum three packs/day (8.4 g/pack) to achieve optimal doses of RAASi without hyperkalaemia. The run‐in phase will last up to 12 weeks, following which patients will undergo double‐blind randomization in a 1:1 ratio to receive either continued patiromer or placebo (patiromer withdrawal). The primary endpoint is the mean difference in serum K + from randomization between patiromer and placebo arms. Secondary endpoints will include hyperkalaemia events with K + value >5.5 mEq/L, durable enablement of MRA at target dose, investigator‐reported adverse events of hyperkalaemia, hyperkalaemia‐related clinical endpoints and an overall RAASi use score (using a 0–8‐point scale) comprising all‐cause death, occurrence of cardiovascular hospitalization or usage of comprehensive heart failure medication. Conclusion The DIAMOND trial is designed to determine if patiromer can favourably impact K + control in patients with HFrEF with hyperkalaemia or a history of hyperkalaemia leading to RAASi therapy compromise, and in turn improve RAASi use.
Butler et al. (Sat,) conducted a rct in Heart failure with reduced ejection fraction (HFrEF) and hyperkalaemia (n=820). Patiromer vs. Placebo was evaluated on Mean difference in serum K+ from randomization between patiromer and placebo arms. The DIAMOND trial is designed to evaluate whether patiromer compared to placebo improves serum potassium control in approximately 820 patients with HFrEF and hyperkalemia.