Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Launched by INOVA HEALTH CARE SERVICES · Jun 3, 2020

Keywords

ClinConnect Summary

The Hemodynamic Monitoring to Prevent Adverse Events following Cardiogenic Shock Trial is a research study aimed at understanding how a special monitoring device can help patients recover after experiencing a serious heart condition called cardiogenic shock. This condition occurs when the heart doesn't pump enough blood, leading to low blood pressure and possible organ damage. The study involves people who have been hospitalized for this condition and aims to see if closely tracking their heart's performance with a device can improve their health outcomes once they leave the hospital.

To participate in this trial, you must be at least 18 years old, have had cardiogenic shock, and be able to use a device that connects to the internet and phone. Participants will receive the monitoring device and will be expected to answer some questions about their health over time. It's important to know that this study is currently recruiting participants, and it's open to anyone who meets the eligibility criteria, regardless of gender. If you or someone you know is dealing with heart failure and has recently been hospitalized for cardiogenic shock, this trial could offer a chance to contribute to important research while receiving potential benefits from the monitoring device.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Age ≥ 18 years
• • 3. NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).
• • 4. 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.
• • 5. Patients must have internet and phone access (to allow communication of the implanted device with the researchers).
• Exclusion Criteria:
• • 1. Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.
• • 2. 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.
• • 3. If of childbearing potential with a positive pregnancy test.
• • 4. Transition to hospice care.
• • 5. Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation.
• • 6. Presence of an active, uncontrolled infection.
• • 7. Any condition other than heart failure that could limit survival to less than 6 months
• • 8. Discharge to facility other than acute rehabilitation or to the ambulatory setting.
• • 9. No access to internet or phone.