Clinical trial NCT04419480: Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
Official title: Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiogenic Shock
Heart Failure
Ambulatory Hemodynamic Monitoring
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2020-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Hierarchical primary endpoint
timeFrame: 6 months
Secondary outcomes:
measure: Health related quality of life change from baseline
timeFrame: 2 months and 6 months
measure: All-cause mortality
timeFrame: 6 months
measure: All-cause mortality or cardiovascular hospitalization
timeFrame: 6 months
measure: All-Cause Hospitalization
timeFrame: 6 months
measure: Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)
timeFrame: 6 months
measure: Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP)
timeFrame: 6 months
measure: Achieved guideline directed medical therapy for heart failure
timeFrame: 6 months
measure: Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitoring.
timeFrame: 6 months
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
Study officials:
affiliation: Inova Fairfax Medical Campus
name: Shashank Sinha, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: