Patiromer for the management of hyperkalaemia in patients receiving renin–angiotensin–aldosterone system inhibitors for heart failure: design and rationale of the DIAMOND trial. (9th December 2021)

• Record Type: Journal Article
• Authors: Butler, Javed; Anker, Stefan D.; Siddiqi, Tariq Jamal; Coats, Andrew J.S.; Dorigotti, Fabio; Filippatos, Gerasimos; Friede, Tim; Göhring, Udo‐Michael; Kosiborod, Mikhail N.; Lund, Lars H.; Metra, Marco; Moreno Quinn, Carol; Piña, Ileana L.; Pinto, Fausto J.; Rossignol, Patrick; Szecsödy, Peter; Van Der Meer, Peter; Weir, Matthew; Pitt, Bertram
• Is Part Of: European journal of heart failure. Volume 24:Number 1(2022)
• Page Start: 230
• Page End: 238
• Publication Date: 2021-12-09
• Subjects: Heart failure -- Potassium -- Hyperkalaemia -- Patiromer -- Renin–angiotensin–aldosterone system inhibitors -- Mineralocorticoid receptor antagonists -- Adherence -- Trial design; Heart failure -- Periodicals; Heart Failure -- Periodicals; Insuffisance cardiaque -- Périodiques; Heart failure; Periodicals; 616.129005
• DOI: 10.1002/ejhf.2386
• Languages: English
• ISSNs: 1388-9842

Abstract

Abstract : 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.