NCT06131008尚未招募不适用
DiastologY-Guided MaNAgement of DecoMpensated Heart Failure: A Pilot RandomIzed, Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Recruitment Rate
研究概览
简要总结
More than 30% of people hospitalized with decompensated heart failure return to the hospital within 90 days. Emerging evidence suggests that hemodynamic monitoring with guided management may enhance prognosis and management. Hemodynamic monitoring with echocardiography using diastology and an evidence-informed therapeutic protocol have the potential to achieve this aim in a minimally invasive manner.
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
- Double (Participant, Outcomes Assessor)
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
- •Age ≥18 years at the time of enrolment
- •Decompensated heart failure with reduced ejection fraction (≤40%)
- •Sinus rhythm without conduction abnormalities (second-degree Mobitz II, third-degree, permanent pacemaker)
- •Written informed consent from either the patient or a substitute decision maker
排除标准
- •Mitral annular calcification (at least moderate or severe)
- •Moderate or severe aortic or mitral valvular heart disease, or history of prosthetic mitral valve
- •Atrial fibrillation or flutter
- •History of non-diagnostic echocardiogram
- •Hemodialysis
结局指标
主要结局
Recruitment Rate
时间窗: 12 months (anticipated study duration)
This is calculated as the number of participants enrolled in the study per month.
次要结局
- Compliance with Echocardiograms(12 months (anticipated study duration))
- Follow-Up at 30 and 90 Days(12 months (anticipated study duration))
- Interpretability of Echocardiograms(12 months (anticipated study duration))
- Adherence to Protocol Recommendations(12 months (anticipated study duration))
研究者
Emilie Belley-Cote
Associate Professor
McMaster University
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