Not Yet RecruitingPhase 2

OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosili-cate in Heart Failure -Extension (OPRA-HF Extension)

110 participantsStarted 2026-09-01

Plain-language summary

A multicenter, randomized, controlled study in Sweden (n=110). This study consists of 2 phases: 1) open-label run-in within approximately 2 months, and 2) randomized, double-blinded and placebo-controlled treatment for 6 months. The open-label phase, in turn, consists of three periods: up-titration (normally 1 - 2 weeks, and longer in some cases), correction (maximum 72 hours) and maintenance (4 - 7 weeks).

Who can participate

Age range70 Years

SexALL

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Inclusion criteria

✓. Prior hyperkalemia (S-K\> 5.0 mmol/L or P-K\> 4.8 mmol/L\*) during MRA treatment within last 24 months, and current S-K ≤ 5.0 or P-K ≤ 4.8 mmol/L
✓. Current S-K 4.5-5.0 mmol/L or P-K 4.3-4.8 mmol/L, and potential risk of hyperkalemia as indicated by eGFR 30-45 ml/min/1,73 m2
✓. Current S-K 5.1-5.9 mmol/L or P-K 4.9-5.7 mmol/L

What they're measuring

% of optimizing MRA between Sodium Zirconium Cyclosilicate treated vs control

Timeframe: From enrollment to the end of treatment at 6 months

To demonstrate the efficacy of Sodium Zirconium Cyclosilicate (SZC) on optimizing MRA in HF, SZC vs control.

Timeframe: 6 mopnths

Trial details

NCT IDNCT07576257

SponsorSahlgrenska University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Michael Liangxiong Fu

0739228176 michael.fu@gu.se

View on ClinicalTrials.gov More Heart Failure trials