RecruitingNot applicable

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

VA