JPRN-jRCTs031220568招募中Unknown
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:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 266
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 90age old（—）
- 性别
- All
入选标准
- •(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
排除标准
- •(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
研究者
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