A Randomized, Controlled Trial Investigating the Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With a Reduced Ejection Fraction With Limited Standardized Kidney Function Assessments (RESUME-HF-Kidney)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 344
- 试验地点
- 4
- 主要终点
- The achieved average percentage dose of reno-active GDMT at 6 months relative to optimal dose.
研究概览
简要总结
Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) constitutes of four medications that substantially reduce morbidity and mortality, and improve quality of life. In routine clinical practice, various physician- and patient-related factors lead to suboptimal initiation and uptitration of GDMT to optimal dosing, which is associated with worse patient outcomes. A perceived major barrier to the optimalization of GDMT are changes in kidney function and electrolytes, which prompts physicians to halt uptitration, reduce doses, or even discontinue GDMT. Changes in kidney function and electrolytes during optimalization of GDMT are common, but not associated with adverse events.
The hypothesis of this study is that a reduction in the number of kidney function assessments during initiation and uptitration of GDMT in HFrEF patients will lead to higher achieved doses of GDMT without safety concerns.
详细描述
Objective: To assess the effect of a reduction in kidney function assessments during optimalization of GDMT in patients with HFrEF on the achieved GDMT doses, safety, and clinical outcomes.
Study design: Randomized, controlled open-label study
Study population: 344 patients with new-onset or sub-optimally treated HFrEF referred to the outpatient clinic for optimalization of GDMT
Intervention (if applicable): Randomization to limited number of kidney function assessments or standard of care
Primary endpoint: The achieved average percentage dose of reno-active GDMT at 6 months relative to optimal dose.
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
- None
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
- •Able and willing to give written informed consent
- •Age ≥ 18 years
- •Diagnosed with HFrEF (LVEF≤ 45%) according to criteria from 2021 European Society of Cardiology guidelines for heart failure
- •Less than 100% target dose of 2 individual reno-active GDMT classes (ACEi/ARB/ARNI, MRA or SGLT-2i)
排除标准
- •eGFR<25 mL/min/1.73 m2 measured up to 30 days before the first visit
- •Potassium > 5.5 mmol/L or <3.5 mmol/L at screening
- •Known intolerance or allergy to two individual GDMT
- •Signs of hemodynamic instability and/or cardiogenic shock
- •Decompensated heart failure requiring treatment with intravenous loop diuretics
- •Known concomitant structural kidney disease such as polycystic kidney disease or renal artery stenosis
结局指标
主要结局
The achieved average percentage dose of reno-active GDMT at 6 months relative to optimal dose.
时间窗: 6 months
次要结局
- The achieved percentage dose of the individual reno-active GDMT drug classes at 6 months relative to optimal dose.(6 months)
- The time to first occurrence of unplanned heart failure visit, heart failure hospitalization, or all-cause mortality till 9 months.(9 months)
研究者
Jozine ter Maaten
Assistant prof. J.M. ter Maaten, MD, PhD
University Medical Center Groningen