Monitoring heart function to prevent complications after cardiogenic shock

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

This study tests if using a special device to monitor heart pressure can help people who have had cardiogenic shock recover better after their hospital stay.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Inova Health Care Services (other)
• Locations: 1 site (Falls Church, Virginia)
• Trial ID: NCT04419480 on ClinicalTrials.gov

What this trial studies

This pilot trial investigates the use of pulmonary artery hemodynamic monitoring in patients who have experienced cardiogenic shock. Participants will receive CardioMEMS implantation for continuous monitoring of pulmonary artery pressure, alongside medication optimization. The study aims to assess whether this approach can improve patient outcomes following hospitalization for cardiogenic shock. It is a randomized, unblinded trial designed to gather preliminary data on the effectiveness of this monitoring strategy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized for cardiogenic shock and meet specific clinical criteria.

Not a fit: Patients who do not have cardiogenic shock or those with NYHA Class IV heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce adverse events and improve recovery in patients recovering from cardiogenic shock.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in hemodynamic monitoring, suggesting potential for success.

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.

Where this trial is running

Falls Church, Virginia

• Inova Fairfax Medical Campus — Falls Church, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Shashank Sinha, MD MSc — Inova Fairfax Medical Campus
• Study coordinator: Shashank Sinha, MD MSc

Conditions: Cardiogenic Shock, Heart Failure, Ambulatory Hemodynamic Monitoring