Phase III, multicenter, randomized, open-label, parallel-group, non-inferiority, phase III clinical trial comparing CSZ (Lokelma) vs. iSRAA discontinuation/reduction and/or ARM (standard treatment).
Patients must present serum potassium levels of 5.5-6.5 mEq/L at patient selection visit (V0)
Patients must present serum potassium levels of 5.0-6.5 mEq/L at randomization visit (V1).
Provision of patient or legal representative informed consent prior to any study specific procedures.
Individuals receiving background standard of care for HF and treated according to locally recognized guidelines. Specific treatment should include RAASi and/or MRA treatment at first consultation and at least should have been stable for ≥ 4 weeks at maximum tolerated doses.
Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
Previous enrollment or randomization in the present study.
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment.