Heart failure
Conditions
Interventions
Trade Name: Lokelma
Product Name: lokelma
Product Code: V03AE10
Pharmaceutical Form: Powder and solvent for oral suspension
Pharmaceutical form of the placebo: Powder for oral suspension
Route of admi
Sponsors
Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study subjects should fulfil the following criteria: 1. Obtain signed informed consent prior to any study specific procedures 2. >18 yrs, irrespective of sex 3. LVEF = 40%, with echocardiography within last 2 years 4. NYHA II-IV 5. Stable heart failure as judged by local Investigator. Patients may be enrolled as an outpatient or in-hospital at, or close to, the time of hospital discharge 6. On optimal treatment with GDMT (Guideline-Directed Medical Treatment including ACE/ARB/ARNI and beta blockers) as per physician´s judgement 7. AND one of followings: (1) Prior hyperkalemia due to MRA therapy and current S-K = 5.0 mmol/L; (2) Risk of hyperkalemia as indicated by eGFR 30-45 ml/min/1.73m2 and S-K 4.5-5.0 mmol/L; (3) Mild hyperkalemia (S-K 5.1-5.5 mmol/L) and MRA below target dose (target doses for spironolactone: 25-50 mg daily, and for eplerenone: 50 mg daily) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: Subjects should not enter the study if any of the following exclusion criteria are ful-filled: 1. Symptomatic hypotension ( 550 msec 12. Currently pregnant (confirmed with positive pregnancy test) or planned pregnancy or breast-feeding 13. Can not sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC) in optimizing MRA in symptomatic patients with heart failure;Secondary Objective: Not applicable;Primary end point(s): To demonstrate the efficacy of Sodium Zir-conium Cyclosilicate (SZC) on optimizing MRA in heart failure, SZC vs Placebo. ;Timepoint(s) of evaluation of this end point: at the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.To determine the efficacy of SZC when com-pared to placebo in maintaining achieved MRA-dose after run-in period, SZC vs Placebo; 2.To determine the impact of MRA-optimization by SZC in QoL-parameters, SZC vs Placebo; 3.To determine the estimated treatment persisten-cy of highest tolerable dose (25-50 mg daily) of MRA, SZC vs Placebo; 4. To evaluate the safety and tolerability of SZC when compared to placebo as assessed by differ-ences in percent (%) between the two groups in pre-specified safety endpoints (occurring at any point during the study);Timepoint(s) of evaluation of this end point: At the end of study and throughtout the study for safety endpoint | — |
Countries
Sweden
Contacts
Public ContactMichael Fu
Sahlgrenska University Hospital
Outcome results
None listed