Heart failure, High-risk hyperkalemia, Suboptimal heart failure treatment
Conditions
Brief summary
To demonstrate the efficacy of Sodium Zirconium Cyclosilicate (SZC) on optimizing MRA in HFrEF, SZC vs Placebo. The efficacy will be assessed by difference in the proportion of patients who may or may not maintain MRA at a dose ≥ 25 mg daily or a dose increase by 25 mg daily and K level in the normal range (3.5-5.0 mmol/L) at the end of study, without rescue therapy due to hy-perkalemia at any point during the randomization phase.
Detailed description
To determine the efficacy of SZC when compared to placebo in maintaining achieved MRA-dose after run-in period, SZC vs Placebo., To determine the impact of MRA-optimization by SZC in QoL-parameters, SZC vs Place-bo., To determine the estimated treatment persistency of highest tolerable dose (25-50 mg dai-ly) of MRA between SZC vs Placebo., To evaluate the safety and tolerability of SZC when compared to placebo as assessed by differences in percent (%) between the two groups in pre-specified safety endpoints (oc-curring at any point during the study)
Interventions
DRUGRELEASE OF UNLABELLED BULK IMP FOR ESR; Product (strength/dosage form): Placebo for Sodium Zirconium Cyclosilicate
powder for oral suspension
Pack size/type: Bulk unlabelled Amcor sachet to match 5 g
Manufacturing lot/batch number
(AstraZeneca/External):
P5D21A04B | L018661
Site of manufacturing (name and
site):
Sharp Packaging Solutions
DRUGAllentown
DRUGUS
Date of bulk manufacture: 01-Nov-2021
Shelf life: 60 months
Storage conditions: Store below 30°C
Sponsor name: Sahlgrenska University Hospital Östra Hospital
Sponsor study reference: ESR-19-20262
DRUG(D9484C00005)
DRUG(OPRA-HF)
EUDRACT number 2020-005176-3
Sponsors
Vaestra Goetalandsregionen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the efficacy of Sodium Zirconium Cyclosilicate (SZC) on optimizing MRA in HFrEF, SZC vs Placebo. The efficacy will be assessed by difference in the proportion of patients who may or may not maintain MRA at a dose ≥ 25 mg daily or a dose increase by 25 mg daily and K level in the normal range (3.5-5.0 mmol/L) at the end of study, without rescue therapy due to hy-perkalemia at any point during the randomization phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the efficacy of SZC when compared to placebo in maintaining achieved MRA-dose after run-in period, SZC vs Placebo., To determine the impact of MRA-optimization by SZC in QoL-parameters, SZC vs Place-bo., To determine the estimated treatment persistency of highest tolerable dose (25-50 mg dai-ly) of MRA between SZC vs Placebo., To evaluate the safety and tolerability of SZC when compared to placebo as assessed by differences in percent (%) between the two groups in pre-specified safety endpoints (oc-curring at any point during the study) | — |
Countries
Sweden
Outcome results
None listed