Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction: a Prospective, Multicentre, International Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Weighed composite score of maximal guideline-directed medical therapy
研究概览
简要总结
The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a weighed composite score.
Participants will be randomized towards control (standard of care, SOC) or intervention group.
Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the study design, the study is open-label. In order to reduce bias, a study nurse (blinded for allocation arm) will see or call the patient to register the heart failure medication and dose of loop diuretics at three months and optionally 12months (open-label, endpoint-blinded).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left ventricular ejection fraction ≤ 40%, assessed LVEF with imaging within last three months before randomization (TTE/KT/MIBI/MRI)
- •NYHA ≥ II
排除标准
- •Hemodynamic instability
- •Recent acute coronary syndrome (< 1 month before randomisation)
- •Already on quadruple heart failure therapy or on triple GDMT in case of eGFR < 30ml/min/1.73m2 or a potassium above 6mmol/L
- •eGFR < 20ml/min/1.73², planned for dialysis or already actively treated with chronic dialysis.
- •Implantation of a cardiac resynchronization therapy (CRT) within 3 months
- •Adult congenital heart disease
- •Previous heart transplantation or currently/planned for ventricular assist device
- •Women who are pregnant or breastfeeding
- •Unable to participate in 3 months follow-up
研究组 & 干预措施
Standard of Care
Up-titration of GDMT at the discretion of the treating physician.
干预措施: SOC (Procedure)
Intervention
Uptitration of GDMT according to the renal-based approach postulated by the Heart Failure Association of the European Society of Cardiology (HFA-ESC)
干预措施: Protocolized up-titration (Procedure)
结局指标
主要结局
Weighed composite score of maximal guideline-directed medical therapy
时间窗: 3 months
The composite score of maximal guideline-directed medical therapy 3 months after inclusion.(minimum score 0, maximum score 15)
次要结局
- Change in renal function(3 months)
- All-cause mortality and heart failure hospitalizations(3 months)
- Change in NTproBNP(3 months)