Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Not Applicable

Recruiting

• Conditions: Heart Failure; Cardiogenic Shock; Ambulatory Hemodynamic Monitoring
• Interventions: Device: CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization

• Registration Number: NCT04419480
• Lead Sponsor: Inova Health Care Services

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-05
• Study Start: 2020-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CardioMEMS Implant Group	CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization	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.

Primary Outcome Measures

Name	Time	Method
Hierarchical primary endpoint	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

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	6 months	All-cause mortality from enrollment.
Health related quality of life change from baseline	2 months and 6 months	Health related quality of life change from baseline, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as a continuous score at 2 months and 6 months following admission for CS.hemodynamic monitor is safe in the high-risk CS population.
All-cause mortality or cardiovascular hospitalization	6 months	Time to first all-cause mortality or cardiovascular hospitalization.
Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)	6 months	Time to all unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)
Achieved guideline directed medical therapy for heart failure	6 months	Achieved guideline directed medical therapy for heart failure with reduced ejection fraction at 6 months, measured by achievement of \>50% of the guideline targeted optimal dosing of angiotensin receptor blocker or angiotensin converting enzyme inhibitor or angiotensin receptor neprilysin inhibitor, beta-blocker, and mineralocorticoid receptor antagonist.
All-Cause Hospitalization	6 months	Time to all-cause hospitalization.
Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP)	6 months	Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP) from enrollment to 6 months follow up.
Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitoring.	6 months	Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitor in the high-risk CS population, including device-related or system-related complications or pressure-sensor failures.

Trial Locations

Locations (1)

Inova Fairfax Medical Campus; 🇺🇸 Falls Church, Virginia, United States