Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

NCT ID: NCT04419480

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CardioMEMS Implant Group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Non-CardioMEMS Implant Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shashank Sinha, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Inova Fairfax Medical Campus

Locations

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shashank Sinha, MD MSc

Role: CONTACT

shashank.sinha@inova.org

7037764001

Bhruga Shah, MPH

Role: CONTACT

Bhruga.shah@inova.org

17037762828

Facility Contacts

Bhruga Shah, MS, BSN

Role: primary

Bhruga.shah@inova.org

703-776-2828

Kedir Seid

Role: backup

kedir.Seid@inova.org

17037762524

Other Identifiers

U19-05-3608

Identifier Type: -

Identifier Source: org_study_id