Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With … (NCT04676646) | Clinical Trial Compass
CompletedPhase 4
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
United States366 participantsStarted 2021-03-08
Plain-language summary
The main objective of this study is to evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue therapy for hyperkalaemia (HK).
Who can participate
Age range18 Years – 130 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA
* Adults aged ≥18 years
* Potassium and estimated glomerular filtration rate (eGFR):
* Cohort 1: sK+ 5.1-5.9 mEq/L at screening/study enrolment and eGFR ≥30 mL/min/1.73 m2; OR
* Cohort 2: Normokalaemic (sK+ 3.5-5.0 mEq/L) at screening and 'at risk' of developing HK defined as any of the following:
* Have a history of HK (sK+ \>5.0 mEq/L) within the prior 36 months and eGFR ≥30 mL/min/1.73 m2; or
* sK+ 4.5-5.0 mEq/L and eGFR 30 to 60 mL/min/1.73 m2; or
* sK+ 4.5-5.0 mEq/L, and age \>75 years
* Symptomatic HFrEF (New York Heart Association \[NYHA\] class II-IV), which has been present for at least 3 months
* Left ventricular ejection fraction (LVEF) ≤40%
* Receiving angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or angiotensin receptor-Neprilysin inhibitor (ARNi)
* Not on or on low-dose spironolactone or eplerenone (\<25 mg daily)
* Receiving beta-blocker unless contraindicated
EXCLUSION CRITERIA
* Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or severe stenotic valve disease as a primary cause of HF
* Current inpatient hospitalisation with unstable HF, defined as any of the following:
* Systolic blood pressure \<95 mmHg during the 6 hours prior to screening.
* Intravenous diuretic therapy during the 12 hours prior to screening.
* Use of intravenous inotropic drugs during the 24 hours prior to screening.
* Received mechanical…
What they're measuring
1
Participants Who Achieved Response, Defined as Serum Potassium (sK+) Within 3.5 to 5.0 mEq/L, Spironolactone Greater Than or Equal to 25 mg Daily, no Rescue Therapy for Hyperkalaemia
Timeframe: From Month 1 (Visit 9) to Month 6 (Visit 14), up to 6 months