[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639338":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":24,"studyPopulation":16,"armGroups":25,"interventions":36,"overallOfficials":16,"centralContacts":41,"locations":16,"responsibleParty":47,"collaborators":16,"id":51,"slug":16,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":16,"enrollmentInfo":59,"targetDuration":16,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":70,"whyStopped":16,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":16},{"fullName":5,"class":6},"Sahlgrenska University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"% 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",{"measure":14,"description":11,"timeFrame":15},"To demonstrate the efficacy of Sodium Zirconium Cyclosilicate (SZC) on optimizing MRA in HF, SZC vs control.","6 mopnths",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":20,"primaryPurpose":21,"observationalModel":16,"timePerspective":16,"maskingInfo":22},"RANDOMIZED","PARALLEL","randomized, but open control","TREATMENT",{"masking":23,"maskingDescription":16,"whoMasked":16},"NONE","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.\n\nThe 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).\n\nEligible study population:\n\n1. \\>70 yrs.\n2. 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\u002Fm2, female \\>95 g\u002Fm2; relative wall thickness ≥0.42; E\u002Fe' ≥15 in sinus rhythm (or \\> 11 in the setting of atrial fibrillation); tricuspid regurgitation velocity \\>2.8 m\u002Fs; Left atrial volume index \\>34 ml\u002Fm2.\n3. GFR ≥ 20 mL\u002Fmin\u002F1,73 m².\n4. NYHA II-IV.\n5. On optimal treatment as per physician´s judgement including ACE\u002FARB\u002FARNI, beta blockers, SGLT2 inhibitor för HFrEF\u002FHFmrEF, and SGLT2 inhibitors in HFpEF\n6. Suboptimal treatment with MRA (defined as: no use or ≤ 25 mg daily\n7. And one of following:\n\n1\\) Prior hyperkalemia (S-K\\> 5.0 mmol\u002FL or P-K\\> 4.8 mmol\u002FL\\*) during MRA treatment within last 24 months, and current S-K ≤ 5.0 or P-K ≤ 4.8 mmol\u002FL 2) Current S-K 4.5-5.0 mmol\u002FL or P-K 4.3-4.8 mmol\u002FL, and potential risk of hyperkalemia as indicated by eGFR 30-45 ml\u002Fmin\u002F1,73 m2 3) Current S-K 5.1-5.9 mmol\u002FL or P-K 4.9-5.7 mmol\u002FL\n\n* 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\u002FL or S-K \\>5,0 mmol\u002FL.\n\nDetailed inclusion and exclusions are described in Clinical Trial Org (NCT 047809239)",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"Sodium Zirconium Cyclosilicate treated","ACTIVE_COMPARATOR","Sodium Zirconium Cyclosilicate",[31],"Drug: potassium binder",{"label":33,"type":34,"description":35,"interventionNames":16},"Control","NO_INTERVENTION","Usual care as per judgement of treating physician",[37],{"type":38,"name":39,"description":29,"armGroupLabels":40,"otherNames":16},"DRUG","potassium binder",[27],[42],{"name":43,"role":44,"phone":45,"phoneExt":16,"email":46},"Michael Liangxiong Fu","CONTACT","0739228176","michael.fu@gu.se",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Michael Fu","Professor","100639338",false,"NCT07576257","OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosili-cate in Heart Failure -Extension (OPRA-HF Extension)","OPRA-HF Extens","Inclusion Criteria:\n\n* 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\u002Fm2, female \\>95 g\u002Fm2; relative wall thickness ≥0.42; E\u002Fe' ≥15 in sinus rhythm (or \\> 11 in the setting of atrial fibrillation); tricuspid regurgitation velocity \\>2.8 m\u002Fs; Left atrial volume index \\>34 ml\u002Fm2.\n\n  3\\. GFR ≥ 20 mL\u002Fmin\u002F1,73 m². 4. NYHA II-IV. 5. On optimal treatment as per physician´s judgement including ACE\u002FARB\u002FARNI, beta blockers, SGLT2 inhibitor för HFrEF\u002FHFmrEF, and SGLT2 inhibitors in HFpEF 6. Suboptimal treatment with MRA (defined as: no use or ≤ 25 mg daily 7. And one of following:\n  1. Prior hyperkalemia (S-K\\> 5.0 mmol\u002FL or P-K\\> 4.8 mmol\u002FL\\*) during MRA treatment within last 24 months, and current S-K ≤ 5.0 or P-K ≤ 4.8 mmol\u002FL\n  2. Current S-K 4.5-5.0 mmol\u002FL or P-K 4.3-4.8 mmol\u002FL, and potential risk of hyperkalemia as indicated by eGFR 30-45 ml\u002Fmin\u002F1,73 m2\n  3. Current S-K 5.1-5.9 mmol\u002FL or P-K 4.9-5.7 mmol\u002FL\n\n     * 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\u002FL or S-K \\>5,0 mmol\u002FL.\n\n     Exclusion Criteria:","ALL","70 Years",{"count":60,"type":61},110,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","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.\n\nThe 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).",[67],"Heart Failure",[69],"effect","NOT_YET_RECRUITING","2026-05-03",{"date":73,"type":74},"2026-05-08","ACTUAL",{"date":76,"type":61},"2026-09-01",{"date":78,"type":61},"2030-06-30",{"name":5,"class":6}]