Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Обзор

Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock

Вмешательства

• Устройство CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization
  Implantation of CardioMEMS Device in patients following admission for Cardiogenic shock, with regular ambulatory pulmonary artery pressure monitoring and medication optimization for the treatment of heart failure.

Первичные конечные точки

• Hierarchical primary endpoint [Срок оценки: 6 months]

Вторичные конечные точки (8)

• Health related quality of life change from baseline [Срок оценки: 2 months and 6 months]
• All-cause mortality [Срок оценки: 6 months]
• All-cause mortality or cardiovascular hospitalization [Срок оценки: 6 months]
• All-Cause Hospitalization [Срок оценки: 6 months]
• Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic) [Срок оценки: 6 months]
• Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP) [Срок оценки: 6 months]
• Achieved guideline directed medical therapy for heart failure [Срок оценки: 6 months]
• Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitoring. [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Inova Fairfax Medical Campus — Falls Church

Идентификаторы

NCT: NCT04419480 · U19-05-3608

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗