The role of sodium zirconium cyclosilicate in uptitrating spironolactone in patients with heart failure with reduced ejection fraction and at high-risk for hyperkalemia - REGISTA-K

Kida Keisuke0 个研究点目标入组 266 人开始时间: 2023年1月13日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•(1) Individuals who have been briefed on the nature of the study and provided written informed consent to participate in the study
•(2) Aged 20 to 90 years old
•(3) Left ventricular ejection fraction of less than 50%
•(4) Estimated glomerular filtration rate (eGFR) of 15-45 mL/min/1.73 m2
•(5) Potassium level exceeds 5.0 mEq/L
•(6) Spironolactone has been introduced at 12.5-37.5 mg
•(7) NT-proBNP level of more than 400 pg/mL (if the patient had a history of hospitalization for heart failure)
•(8) NT-proBNP level of more than 600 pg/mL (if the patient had no history of heart failure hospitalization)
•(9) Currently taking a beta-blocker and either an ACE inhibitor/ARB/ARNi (regardless of dose), unless contraindicated

•(1) Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or organic valvular disease
•(2) Renal artery stenosis
•(3) Chronic dialysis (hemodialysis, peritoneal dialysis)
•(4) Use of NSAIDs within 1 week and/or inability to discontinue
•(5) QT prolongation; QTc (f) >550 msec
•(6) Symptomatic bradycardia without pacemaker or concomitant symptomatic II (Mobitz type 2) or III degree AV block
•(7) History of drug-induced QT prolongation with drug discontinuation
•(8) Congenital long QT syndrome
•(9) Use of lactulose, rifaximin, or other non-absorbable antibiotics for hyperammonemia
•(10) Use of resin (sevelamer acetate, sodium polystyrene sulfonate, etc.), calcium acetate, calcium carbonate, or lanthanum carbonate within 7 days prior to the first dose of the study drug
•(11) Patients who are pregnant or lactating or those who wish to become pregnant during the study period
•(12) Use of potassium-lowering drugs other than study drugs (calcium polystyrene sulfonate, sodium polystyrene sulfonate)
•(13) Patients who are already taking over 50 mg of spironolactone
•(14) Symptomatic or uncontrolled atrial fibrillation despite treatment or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
•(15) Patients who are judged to be unsuitable for enrollment by the principal investigator or sub-investigator

发起方

Kida Keisuke