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Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial | Clinical Trials | Clareo Health

RECRUITINGNA

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

NCT04419480•Inova Health Care Services

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Key Dates

Start Date

December 31, 2020

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2028

Last Updated

March 16, 2026

Enrollment

ESTIMATED participants

Conditions

Cardiogenic ShockHeart FailureAmbulatory Hemodynamic Monitoring

Interventions

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

DEVICE

Contacts

Shashank Sinha, MD MSc

CONTACT

7037764001 shashank.sinha@inova.org

Bhruga Shah, MPH

CONTACT

17037762828 Bhruga.shah@inova.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Inclusion Criteria

Exclusion Criteria

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