Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial (HALO-Shock)

Inova Health Care Services

Status: Enrolling

Conditions: Ambulatory Hemodynamic Monitoring; Heart Failure; Cardiogenic Shock

Treatments: Device: CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04419480

U19-05-3608

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

CardioMEMS Implant Group

Experimental group

Description:

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.

Treatment:

Device: CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization

Non-CardioMEMS Implant Group

No Intervention group

Description:

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.