NCT07576257Not yet recruitingPhase 2
OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosili-cate in Heart Failure -Extension (OPRA-HF Extension)
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 3 May 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Sahlgrenska University Hospital
- Diseases
- Heart failure
- NCT number
- NCT07576257
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 110
- From 1 Sept 2026 to the primary completion date, 31 Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 1\. \>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.
- 3\. 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.
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.