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

Sponsor
Sahlgrenska University Hospital
Study ID
NCT07576257
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • potassium binder — DRUG
    Sodium Zirconium Cyclosilicate

Study Details

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).

Key Dates

First listed
May 8, 2026
Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Sodium Zirconium Cyclosilicate treated
    Sodium Zirconium Cyclosilicate
  • No Intervention: Control
    Usual care as per judgement of treating physician

Primary Outcome Measure

% of optimizing MRA between Sodium Zirconium Cyclosilicate treated vs control [ Time Frame: From enrollment to the end of treatment at 6 months ]

Central Contacts

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