OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure
Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
Summary
Mineralocorticoid receptor antagonists (MRA) is one of cornerstones in the treatment of heart
failure with reduced ejection fraction (HFrEF). However, MRA has been extremely under-used
globally. The main reason for this seems to be increased risk of hyperkalemia in individuals
on MRA. Theoretically, by limiting the risk of hyperkalemia it could thus be possible to
optimize MRA therapy. This is studied in this randomized controlled trial in which it is
investigated whethere adding a potassium-binder in combination with MRA treatment prevent
hyperkalemia to a greater extent than only using MRA.
The specific aim of this study is to demonstrate the efficacy and safety of Sodium Zirconium
Cyclosilicate (SZC) in optimizing MRA in symptomatic patients with HFrEF.
A multicenter, randomized, placebo-controlled, double-blinded study in Sweden (n=230)
The study consists of 2 phases: 1) open-label run-in within maximum 2 months, where all are
treated with SZC to test tolarability, and 2) a 1:1 randomized, double-blinded and
placebo-controlled treatment during 6 months.
The open-label phase, in turn, consists of three periods: run-in (1 - 2 weeks), correc-tion
(maximum 72 hours) and maintenance (at least 4 weeks)
Sodium Zirconium Cyclosilicate (SZC) (Lokelma)®, 5 g, 10 g, orally, is an approved drug in
Sweden. For correction of hyperkalemia, the recommended starting dose is 10 g, three times
daily. Once normokalemia has been achieved, the maintenance reg-imen should be started with 5
g once daily. The dose can be titrated up to 10 g once daily or lowered to 5 g once every
other day as needed, to maintain a normal level of potassium.
Primary Objective:
To demonstrate the efficacy of Sodium Zirconium Cyclosilicate (SZC) on optimiz-ing MRA in
HFrEF, SZC vs Placebo.
Primary Outcome Measure:
Whether a patient maintains MRA at a dose ≥ 25 mg daily and S-K level in the normal range
(3.5-5.0 mmol/L) at the end of study, without rescue therapy due to hyperkalemia at any point
during the randomization phase.