drugset / Trial / NCT07576257

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

NCT07576257

Phase 2 Not yet recruiting 110 enrolled Sahlgrenska University Hospital
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2026-09-01
Primary completion
2029-12-31
Completion
2030-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sodium Zirconium Cyclosilicate Other / unclassified

Indications