Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

NCT04419480 | Recruiting DMC FDA Device

• 1 other identifier: U19-05-3608
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiogenic Shock; Heart Failure; Ambulatory Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

• Hierarchical primary endpoint

  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

  6 months

Secondary Outcomes (8)

• Health related quality of life change from baseline

  2 months and 6 months

• All-cause mortality

  6 months

• All-cause mortality or cardiovascular hospitalization

  6 months

• All-Cause Hospitalization

  6 months

• Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)

  6 months

Study Arms (2)

CardioMEMS Implant Group

EXPERIMENTAL

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.

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

Non-CardioMEMS Implant Group

NO INTERVENTION

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.

Interventions

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

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.

CardioMEMS Implant Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inova Health Care Services: lead
• Abbott: collaborator

Study Sites (1)

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Shashank Sinha, MD MSc

  Inova Fairfax Medical Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shashank Sinha, MD MSc

CONTACT

7037764001; shashank.sinha@inova.org

Bhruga Shah, MPH

CONTACT

17037762828; Bhruga.shah@inova.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: December 31, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)