Hemodynamic Monitoring to Prevent Adverse Events foLlowin... | NCT04419480

Status Module

Name	Class
Abbott	INDUSTRY

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Health related quality of life change from baseline	Health related quality of life change from baseline, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as a continuous score at 2 months and 6 months following admission for CS.hemodynamic monitor is safe in the high-risk CS population.	2 months and 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Name	Role	Phone	Extension	Email
Shashank Sinha, MD MSc	Contact	7037764001		shashank.sinha@inova.org
Bhruga Shah, MPH	Contact	17037762828		Bhruga.shah@inova.org

ID	Term
D012770	Shock, Cardiogenic
D006333	Heart Failure

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis
D012769	Shock