Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hierarchical primary endpoint
研究概览
简要总结
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
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
- •Subject or legal representative has signed Informed Consent Form (ICF) and the patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator.
- •Age ≥ 18 years
- •NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).
- •Survive to discharge during a current hospital admission with cardiogenic shock (CS) as defined by clinical criteria previously used in cardiogenic shock trials: systolic blood pressure < 90 mmHg for > 30 minutes or requiring infusion of catecholamines to maintain the systolic blood pressure above 90 mmHg, with evidence of end-organ dysfunction such as pulmonary edema or impaired end-organ perfusion including altered mentation, oliguria with urine output < 30 mL/h, or serum lactate > 2 mmol/L (5). Hemodynamic criteria include cardiac index ≤ 1.8 L/min/m2 without vasoactive pharmacologic agents, or cardiac index ≤ 2.2 L/min/m2 and pulmonary artery occlusion pressure ≥ 15 mmHg with vasoactive agents.
- •Patients must have internet and phone access (to allow communication of the implanted device with the researchers).
排除标准
- •Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.
- •Treatment with ongoing mechanical circulatory support (MCS) such as a durable left ventricular assist device (LVAD) or recipient of a heart transplantation for the treatment of cardiogenic shock during the index hospitalization for CS.
- •If of childbearing potential with a positive pregnancy test.
- •Transition to hospice care.
- •Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation.
- •Presence of an active, uncontrolled infection.
- •Any condition other than heart failure that could limit survival to less than 6 months
- •Discharge to facility other than acute rehabilitation or to the ambulatory setting.
- •No access to internet or phone.
研究组 & 干预措施
CardioMEMS Implant Group
Following enrollment, patients randomized 1:1 to post-discharge implantation of the CardioMEMS device will receive that device ≤14 days following discharge from the index hospitalization for Cardiogenic Shock, in addition to local standard of care medical therapy.
干预措施: CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization (Device)
Non-CardioMEMS Implant Group
Following enrollment, patients randomized 1:1 to post-discharge standard of care will be treated according to local standard of care medical therapy following their index hospitalization for Cardiogenic Shock.
结局指标
主要结局
Hierarchical primary endpoint
时间窗: 6 months
Hierarchical endpoint at 6-months, including death (or mortality-equivalent including left ventricular assist device implantation or heart transplantation), recurrent cardiovascular hospitalization, health related quality of life change from baseline, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as a continuous score, and change in log-transformed NT-proBNP level from enrollment to 6 months, evaluated by the win ratio according to the Finkelstein-Schoenfeld method
次要结局
- All-cause mortality(6 months)
- Health related quality of life change from baseline(2 months and 6 months)
- All-cause mortality or cardiovascular hospitalization(6 months)
- Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)(6 months)
- Achieved guideline directed medical therapy for heart failure(6 months)
- All-Cause Hospitalization(6 months)
- Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP)(6 months)
- Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitoring.(6 months)