DiastologY-Guided MaNAgement of DecoMpensated Heart Failure: A Pilot RandomIzed, Controlled Trial
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
研究组 & 干预措施
Diastology-Guided Management
Participants in this arm will undergo a focused echocardiogram every 24 hours. The degree of diastolic dysfunction will be reported to the healthcare team. If the degree of diastolic dysfunction is greater than or equal to grade 2, the research team will recommend escalating the diuretic regimen if either (1) urine output is less than 4,000 mL over 24 hours or (2) weight loss is less than 2 kg over 24 hours. If the degree of diastolic dysfunction is grade 1, the research team will recommend transitioning to or discontinuing oral diuresis.
干预措施: Diastology (Diagnostic Test)
Diastology-Guided Management
Participants in this arm will undergo a focused echocardiogram every 24 hours. The degree of diastolic dysfunction will be reported to the healthcare team. If the degree of diastolic dysfunction is greater than or equal to grade 2, the research team will recommend escalating the diuretic regimen if either (1) urine output is less than 4,000 mL over 24 hours or (2) weight loss is less than 2 kg over 24 hours. If the degree of diastolic dysfunction is grade 1, the research team will recommend transitioning to or discontinuing oral diuresis.
干预措施: Diastology-Guided Diuresis (Behavioral)
Usual Care
Participants in this arm will also undergo a focused echocardiogram every 24 hours. However, the results of these echocardiograms will not be available for clinical decision-making. Instead, participants will receive usual care by the healthcare team without daily hemodynamic parameters from a study echocardiogram.
干预措施: Diastology (Diagnostic Test)
Usual Care
Participants in this arm will also undergo a focused echocardiogram every 24 hours. However, the results of these echocardiograms will not be available for clinical decision-making. Instead, participants will receive usual care by the healthcare team without daily hemodynamic parameters from a study echocardiogram.
干预措施: Usual Care (Behavioral)
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