Recruiting NCT04419480

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

No phase Interventional Cardiogenic Shock Heart Failure Ambulatory Hemodynamic Monitoring

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization.
Who it may be relevant to: Registry conditions: Cardiogenic Shock, Heart Failure, Ambulatory Hemodynamic Monitoring. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock

Device 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.

Secondary outcome measures (8)

Health related quality of life change from baseline [Time frame: 2 months and 6 months]
All-cause mortality [Time frame: 6 months]
All-cause mortality or cardiovascular hospitalization [Time frame: 6 months]
All-Cause Hospitalization [Time frame: 6 months]
Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic) [Time frame: 6 months]
Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP) [Time frame: 6 months]
Achieved guideline directed medical therapy for heart failure [Time frame: 6 months]
Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitoring. [Time frame: 6 months]

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).

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT04419480 · U19-05-3608