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Patiromer for the management of hyperkalaemia in patients receiving renin–angiotensin–aldosterone system inhibitors for heart failure : design and rationale of the DIAMOND trial
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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 and Pitt, Bertram (2022) Patiromer for the management of hyperkalaemia in patients receiving renin–angiotensin–aldosterone system inhibitors for heart failure : design and rationale of the DIAMOND trial. European Journal of Heart Failure, 24 (1). pp. 230-238. doi:10.1002/ejhf.2386 ISSN 1388-9842.
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WRAP-patiromer-management-hyperkalaemia-patients-receiving-renin–angiotensin–aldosterone-system-inhibitors-heart-failure-2021.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons: Attribution-Noncommercial 4.0. Download (1340Kb) | Preview |
Official URL: https://doi.org/10.1002/ejhf.2386
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.
| Item Type: | Journal Article | ||||||||
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| Subjects: | Q Science > QD Chemistry Q Science > QP Physiology R Medicine > RC Internal medicine |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||||
| SWORD Depositor: | Library Publications Router | ||||||||
| Library of Congress Subject Headings (LCSH): | Heart failure -- Treatment, Heart failure -- Patients -- Rehabilitation, Renin-angiotensin system, Potassium, Mineralocorticoids | ||||||||
| Journal or Publication Title: | European Journal of Heart Failure | ||||||||
| Publisher: | John Wiley & Sons Ltd. | ||||||||
| ISSN: | 1388-9842 | ||||||||
| Official Date: | January 2022 | ||||||||
| Dates: |
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| Volume: | 24 | ||||||||
| Number: | 1 | ||||||||
| Page Range: | pp. 230-238 | ||||||||
| DOI: | 10.1002/ejhf.2386 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||||
| Date of first compliant deposit: | 9 February 2022 | ||||||||
| Date of first compliant Open Access: | 10 February 2022 | ||||||||
| RIOXX Funder/Project Grant: |
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