Myocardial Reserve in Advanced Heart Failure Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Cardiac output measurement using a pulmonary artery (PA) catheter measuring mmHg at 2 years
研究概览
简要总结
The main purpose of this study is to determine whether differences in myocardial reserve predict clinical outcomes for heart failure patients.
详细描述
This study is designed as a prospective, observational, crossover study to assess the feasibility of using differences in invasive hemodynamics of cardiac function, representing myocardial reserve, to predict clinical outcomes for heart failure patients. Patients with heart failure referred for right heart catheterization (RHC) by the advanced heart failure team as part of 1) evaluation for advanced heart failure therapies, including left ventricular assist device (LVAD), orthotopic heart transplant (OHT), temporary or long-term inotrope therapy, or counter-pulsation (temporary intra-aortic balloon pump (IABP) or long-term with NuPulse device), 2) for accurate assessment of invasive hemodynamics due to worsening clinical status, 3) assessment of myocardial recovery for consideration of LVAD or NuPulse decommissioning or removal or mechanical circulatory support removal, or 4) accurate assessment of cardiac function in patients with reduced LVEF prior to valve replacement for aortic insufficiency (AI) or mitral regurgitation (MR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Referred for RHC for:
- •Evaluation for advanced heart failure therapies, including LVAD, OHT, temporary or long-term inotrope therapy, or counter-pulsation (temporary or long-term with NuPulse device OR
- •Accurate assessment of invasive hemodynamics due to worsening clinical status, OR
- •Assessment of myocardial recovery for consideration of LVAD or counter-pulsation (temporary IABP or long-term with NuPulse device) decommissioning or removal OR
- •Assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for MR or AI
- •Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2
- •Age ≥ 18 years-old
- •Intent for admission based on RHC data
排除标准
- •eGFR < 30 ml/min/1.73 m2
- •Severe, non-revascularized coronary artery disease
- •Concurrent acute coronary syndrome
- •Age < 18 years-old
- •History of significant ventricular arrhythmia without an ICD
研究组 & 干预措施
1:1 No Intervention
Subjects without evidence of cardiogenic shock will not receive Milrinone.
1:1 Randomization to Milrinone
Milrinone will be given as a bolus dose of 50 mcg/kg. If a maintenance milrinone infusion is felt to be necessary, it will be maintained at 0.125-0.375 mcg/kg/min.
干预措施: 1:1 Randomization to receive milrinone (Drug)
结局指标
主要结局
Cardiac output measurement using a pulmonary artery (PA) catheter measuring mmHg at 2 years
时间窗: 2 years
Efficacy of increasing cardiac output with milrinone compared to dobutamine using changes invasive hemodynamics in 5 patients using a pulmonary artery (PA) catheter: Pulmonary capillary wedge pressure (PCWP mmHg), Right Atrial pressure (RA mmHg), Pulmonary Atrial pressures (PA mmHg),
Inotropes
时间窗: 2 years
Duration of time on inotropes during hospitalization
Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring mmHg
时间窗: Baseline and 6,12,24,36,72 Hours post-inotrope challenge.
Changes invasive hemodynamics representing myocardial reserve will be measured in 5 patients using a pulmonary artery (PA) catheter: Pulmonary capillary wedge pressure (PCWP mmHg); Right Atrial pressure (RA mmHg); Pulmonary Atrial pressures (PA mmHg);
Advanced heart failure therapy
时间窗: 2 years
Duration of time without need for definitive advanced heart failure therapy (LVAD, OHT) or death.
Death
时间窗: 2 years
Cardiovascular death and/or all-cause mortality
Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring L/min/m2
时间窗: Baseline and 6,12,24,36,72 Hours post-inotrope challenge.
Changes invasive hemodynamics representing myocardial reserve will be measured in 5 patients using a pulmonary artery (PA) catheter: Cardiac output by Fick (CO L/min/m2); Cardiac index by Fick (CI L/min/m2).
Cardiac output measurement using a pulmonary artery (PA) catheter measuring CO L/min/m2 at 2 years
时间窗: 2 years
Efficacy of increasing cardiac output with milrinone compared to dobutamine using changes invasive hemodynamics in 5 patients using a pulmonary artery (PA) catheter: Cardiac output by Fick (CO L/min/m2), Cardiac index by Fick (CI L/min/m2.)
次要结局
- LVAD decommissioning measuring mmHg(2 years)
- Durable support(72 hours)
- Hospital discharge(Up to 12 weeks)
- Home inotropic(2 years)
- LVAD decommissioning measuring L/min/m2(2 years)
- Durable support(6 hours)
- Durable support(12 hours)
- Durable support(24 hours)
- Durable support(36 hours)
- Durable support(48 hours)