NCT04419480 Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
| NCT ID | NCT04419480 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inova Health Care Services |
| Condition | Cardiogenic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-12-31 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2020-12-31 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
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.
Contact & Investigator
Shashank Sinha, MD MSc
PRINCIPAL INVESTIGATOR
Inova Fairfax Medical Campus
Frequently Asked Questions
Who can join the NCT04419480 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04419480 currently recruiting?
Yes, NCT04419480 is actively recruiting participants. Contact the research team at shashank.sinha@inova.org for enrollment information.
Where is the NCT04419480 trial being conducted?
This trial is being conducted at Falls Church, United States.
Who is sponsoring the NCT04419480 clinical trial?
NCT04419480 is sponsored by Inova Health Care Services. The principal investigator is Shashank Sinha, MD MSc at Inova Fairfax Medical Campus. The trial plans to enroll 40 participants.