학술논문
Patiromer for the management of hyperkalaemia in patients receiving renin-angiotensin-aldosterone system inhibitors for heart failure: design and rationale of the DIAMOND trial.
Document Type
Article
Author
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; Quinn, Carol Moreno; Piña, Ileana L.; Pinto, Fausto J.; Rossignol, Patrick; Szecsödy, Peter; Van Der Meer, Peter; Weir, Matthew; Pitt, Bertram
Source
Subject
*VENTRICULAR ejection fraction
*RENIN-angiotensin system
*ACE inhibitors
*RANDOMIZED controlled trials
*POLYMERS
*HYPERKALEMIA
*HEART failure
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Language
ISSN
1567-4215
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 50mg/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 12weeks, 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. [ABSTRACT FROM AUTHOR]