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Not yet recruiting NCT07576257

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

Phase II Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: potassium binder.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Detailed description

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).

Eligible study population:

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:

1\) 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 2) 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 3) 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.

Detailed inclusion and exclusions are described in Clinical Trial Org (NCT 047809239)

Interventions

  • Drug potassium binder
    Sodium Zirconium Cyclosilicate

Primary outcome measures

  • % of optimizing MRA between Sodium Zirconium Cyclosilicate treated vs control [Time frame: 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. [Time frame: 6 mopnths]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07576257 · OPRAHF EXT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗