CTIS2023-508162-15-00招募中1 期
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function - D6402C00012
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 4,800
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Age = 18 years, 2. Documented diagnosis of symptomatic HF (NYHA functional class II-IV), 3. Having had a recent HF event within 6 months (hospitalization or urgent visit), 4. Have a LVEF value from an assessment within the last 12 months, 5. Managed with SoC therapy for HF and renal impairment according to local guidelines, 6. NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter), 7. Not taking an MRA, 8. An eGFR = 20 to < 60 mL/min/1.73 m2, 9. Serum/plasma potassium = 3.5 mmol/L and = 5.0 mmol/
排除标准
- •1. Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months, 8. Type 1 diabetes mellitus, 9. Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy, 12. Treatment with strong or moderate CYP3A4 inhibitor or inducer, 10. Hepatic disease, including active HBV or HCV infection, or other cause of hepatitis, and/or hepatic impairment (Child-Pugh class A-C), AST or ALT >3 × ULN; or TBL > 2 × ULN at time of screening, 11. Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks, 2. Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or planned to undergo any of these operations, 3. History of hypertrophic obstructive cardiomyopathy, 4. Complex congenital heart disease or severe uncorrected primary valvular disease, 5. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker, 6. Systolic BP < 100 mmHg, or symptomatic hypotension within the past 24 hours, 7. Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment
研究者
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