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

Phase 1

• Conditions: High-risk hyperkalemia, Heart failure, Suboptimal heart failure treatment; MedDRA version: 20.0Level: HLTClassification code: 10019283Term: Heart failure signs and symptoms Class: 10007541; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-511502-24-02
• Lead Sponsor: Vaestra Goetalandsregionen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-25
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Obtain signed informed consent prior to any study specific procedures., >18 yrs, irrespective of sex., LVEF = 40%, with echocardiography within last 2 years including those with recovered EF later on, NYHA II-IV., Stable heart failure as judged by local Investigator. Patients may be enrolled as an outpatient or in-hospital at, or close to, the time of hospital discharge., On optimal treatment including ACE/ARB/ARNI, beta blockers, SGLT2 inhibitor as per physician´s judgement., Suboptimal treatment with MRA (defined as: no use or = 25 mg daily)., AND one of followings: a.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 b.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 (modi-fied MDRD formula) c.Current S-K 5.1-5.9 mmol/L or P-K 4.9-5.7 mmol/

Exclusion Criteria

Symptomatic hypotension (< 90/60 mmHg), Symptomatic and uncontrolled atrial fibrillation despite treatment, or asymp-tomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted, QTc(f) > 550 msec, Currently pregnant (confirmed with positive pregnancy test) or planned pregnancy or breast-feeding, Can not sign informed consent, eGFR < 30 ?ml/min/1,73 m2 (modified MDRD formula), HF due to restrictive cardiomyopathy, hypertrophic (obstructive) cardiomy-opathy or primary valvular disease, Current/recent (within 3 months) hospitalization due to myocardial infarc-tion, unstable angina pectoris, coronary revascularization (percutaneous cor-onary intervention or coronary artery bypass grafting), or other interventions (valvular repair/replacement, cardiac transplantation, or implantation of a ventricular assistance device), Ongoing or planned dialysis, Prior history of hypersensitivity (other than hyperkalemia) to MRA or SZC, Advanced malignancy requiring treatment, History of QT prolongation associated with other medication which required discontinuation of that medication, Congenital long QT syndrome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified