Patiromer for the management of hyperkalaemia in patients receiving renin‐angiotensin‐aldosterone system inhibitors for heart failure: design and rationale of the DIAMOND trial - Université de Lorraine Access content directly
Journal Articles European Journal of Heart Failure Year : 2021

Patiromer for the management of hyperkalaemia in patients receiving renin‐angiotensin‐aldosterone system inhibitors for heart failure: design and rationale of the DIAMOND trial

1 UMMC - University of Mississippi Medical Center
2 Charité Campus Virchow-Klinikum (CVK)
3 Charité - UniversitätsMedizin = Charité - University Hospital [Berlin]
4 DZHK - German Center for Cardiovascular Research
5 BCRT - Berlin-Brandenburg Center for Regenerative Medicine [Berlin, Germany]
6 Department of Internal Medicine, Dow University of Health Sciences
7 University of Warwick [Coventry]
8 Vifor Pharma Ltd [Glattbrugg, Switzerland]
9 NKUA - National and Kapodistrian University of Athens
10 UOA - Université d'Athènes
11 “Attikon” University Hospital
12 UMG - University Medical Center Göttingen
13 UMKC - University of Missouri [Kansas City]
14 Saint Luke's Mid America Heart Institute
15 Karolinska Institutet [Stockholm]
16 UniBs - Università degli Studi di Brescia = University of Brescia
17 Civic Hospital of Brescia
18 CMU - Central Michigan University
19 NOVA - Universidade Nova de Lisboa = NOVA University Lisbon
20 Faculdade de Medicina [Lisboa]
21 Hospital de Santa Maria [Lisboa]
22 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
23 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
24 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
25 Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris]
26 UMCG - University Medical Center Groningen [Groningen]
27 University of Groningen [Groningen]
28 University of Maryland School of Medicine
29 University of Michigan [Ann Arbor]
Javed Butler
Ileana L Piña
Bertram Pitt

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 enrol ~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 HF 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.
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Dates and versions

hal-03467277 , version 1 (06-12-2021)

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Javed Butler, Stefan D Anker, Tariq Jamal Siddiqi, Andrew J S Coats, Fabio Dorigotti, et al.. 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, 2021, ⟨10.1002/ejhf.2386⟩. ⟨hal-03467277⟩
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