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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).
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) 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
Detailed inclusion and exclusions are described in Clinical Trial Org (NCT 047809239)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Zirconium Cyclosilicate treated | Active Comparator | Sodium Zirconium Cyclosilicate |
|
| Control | No Intervention | Usual care as per judgement of treating physician |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| potassium binder | Drug | Sodium Zirconium Cyclosilicate |
|
| Measure | Description | Time Frame |
|---|---|---|
| % 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 |
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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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Liangxiong Fu | Contact | 0739228176 | michael.fu@gu.se |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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randomized, but open control
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