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

NCT07576257 | Not Yet Recruiting Phase 2

• 1 other identifier: OPRAHF EXT
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Heart Failure

Keywords

effect

Outcome Measures

Primary Outcomes (2)

• % of optimizing MRA between Sodium Zirconium Cyclosilicate treated vs control

  The efficacy will be assessed by difference in the proportion of patients who may or may not maintain MRA at a dose ≥ 25 mg da

  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.

  The efficacy will be assessed by difference in the proportion of patients who may or may not maintain MRA at a dose ≥ 25 mg da

  6 mopnths

Study Arms (2)

Sodium Zirconium Cyclosilicate treated

ACTIVE COMPARATOR

Sodium Zirconium Cyclosilicate

Drug: potassium binder

Control

NO INTERVENTION

Usual care as per judgement of treating physician

Interventions

potassium binder DRUG

Sodium Zirconium Cyclosilicate

Sodium Zirconium Cyclosilicate treated

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \. \>70 yrs. 2. Regardless of LVEF but EF measured within past 2 years. For HFpEF echo criteria defined by ≥2 of: LV wall thickness ≥ 12 mm; LV mass index (BSA indexed LVH): male \>115 g/m2, female \>95 g/m2; relative wall thickness ≥0.42; E/e' ≥15 in sinus rhythm (or \> 11 in the setting of atrial fibrillation); tricuspid regurgitation velocity \>2.8 m/s; Left atrial volume index \>34 ml/m2.
• \. GFR ≥ 20 mL/min/1,73 m². 4. NYHA II-IV. 5. On optimal treatment as per physician´s judgement including ACE/ARB/ARNI, beta blockers, SGLT2 inhibitor för HFrEF/HFmrEF, and SGLT2 inhibitors in HFpEF 6. Suboptimal treatment with MRA (defined as: no use or ≤ 25 mg daily 7. And one of following:
• 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
• Corresponding plasma K (P-K) level is 0.2 mmol lower than serum K(S-K). Hyperkalemia is defined as P-K \> 4,8 mmol/L or S-K \>5,0 mmol/L.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Michael Liangxiong Fu

CONTACT

0739228176; michael.fu@gu.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized, but open control

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 8, 2026

Record last verified: 2026-05