2025-522560-32-01招募中4 期
A prospective, randomized, controlled clinical pilot trial investigating the partial down-titration of guideline-directed medical therapy in patients with heart failure in remission
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Left ventricular remodeling, measured in a core echocardiography laboratory as an increase in left ventricular end-systolic volume index of more than 20% from baseline
研究概览
简要总结
To investigate the safety and feasibility of heart failure therapy down-titration versus therapy continuation in patients with heart failure in remission.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 18 years
- •Heart failure in remission, defined as heart failure with an improved ejection fraction to an LVEF above 50%, with normalized LV volumes, an NT-proBNP ≤ 250 pg/mL, normal functional capacity, and clinical stability
- •Patients must receive at least 3 HF therapies (ACEi/ARB/ARNI, BB, and MRA or SGLT2i) for HF, consistent with international HF guidelines. Each therapy must have been titrated to the maximally tolerated dose, stable for at least 6 months prior to screening
排除标准
- •Albuminuric chronic kidney disease
- •Recent major cardiovascular events such as an acute coronary syndrome, CABG, stroke or TIA in the 90 days before screening
- •Uncontrolled hypertension
- •Atrial fibrillation or atrial flutter with a resting heart rate >110 beats per minute
- •Patients with a cardiac resynchronization therapy device who have < 98% biventricular pacing during screening
- •Any sustained ventricular arrythmias within 6 months prior to screening
- •Any untreated valvular heart disease of moderate or greater severity during screening.
- •Presence of any other disease with a life expectancy of < 2 years.
- •Pregnant or lactating women.
结局指标
主要结局
Left ventricular remodeling, measured in a core echocardiography laboratory as an increase in left ventricular end-systolic volume index of more than 20% from baseline
Left ventricular remodeling, measured in a core echocardiography laboratory as an increase in left ventricular end-systolic volume index of more than 20% from baseline
NT-proBNP increase to more than 500 pg/mL
NT-proBNP increase to more than 500 pg/mL
All-cause mortality
All-cause mortality
次要结局
- Time to first occurrence of all-cause mortality or all-cause hospitalizations
- Change in KCCQ-12
- Proportion of patients requiring HF treatment re-initiation or escalation (i.e., (re-)initation of at least one guideline-directed medical therapy or starting a loop diuretic)
研究者
Wilfried Mullens
Scientific
Ziekenhuis Oost Limburg
研究点 (2)
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