EUCTR2020-003312-27-ES招募中1 期
Phase IV, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Trial Evaluating Sodium Zirconium Cyclosilicate (SZC) for the Management of Hyperkalaemia in Patients with Symptomatic Heart Failure with Reduced Ejection Fraction and Receiving Spironolactone (REALIZE-K) - REALIZE-K
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 400
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
- 性别
- All
入选标准
- •- 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.
- •Inclusion Criteria for Proceeding to the 6-month Randomised-Withdrawal Treatment Phase:
- •- NK (3.5-5.0 mEq/L) on SZC and receiving spironolactone =25 mg daily at the end of the 4- to 6-week run-in phase.
- •- Female participants of childbearing potential must have a negative pregnancy test (serum).
- •- Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of 4 months before entering the study and willing to remain on the birth control until 4 weeks after the last dose.
- •Informed Consent
- •- Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this CSP
- •- Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.
- •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 214
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 214
排除标准
- •- 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 hospitalization with unstable HF, defined as any of the following:
- •a. SBP <95 mmHg during the 6 hours prior to screening.
- •b. Intravenous diuretic therapy during the 12 hours prior to screening.
- •c. Use of intravenous inotropic drugs during the 24 hours prior to screening.
- •d. Received mechanical circulatory support during the 48 hours prior to screening.
- •- Type 1 myocardial infarction (MI), unstable angina, or stroke within 12 weeks prior to enrolment
- •- Coronary revascularisation (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these procedures
- •- Implantation of a Cardiac Resynchronisation Therapy (CRT) device within 12 weeks prior to enrolment or intent to perform atrial fibrillation ablation or to implant a CRT device
- •- Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
- •- Clinically significant bradycardia, as per investigator’s judgement, or second- or thirddegree heart block without a pacemaker
- •- Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or transplantation or implantation expected after randomisation
- •- History of gynecomastia due to spironolactone therapy requiring down-titration or discontinuation of spironolactone, or switch to a different MRA
- •Other Exclusions
- •- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- •- Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
- •- Previous enrolment in the present study.
- •- For women only - breast-feeding or planning to become pregnant during the study.
- •- If the participant has evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to enrolment (see Appendix E), the participant cannot be enrolled in the study.
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