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NCT04419480Recruiting

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Source: ClinicalTrials.gov · Last updated 16 Mar 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
3 Jun 2020
Start date
31 Dec 2020
Primary completion date
31 Dec 2028
Lead sponsor
Inova Health Care Services
NCT number
NCT04419480

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 31 Dec 2020 to the primary completion date, 31 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation.

Other illness

  • Presence of an active, uncontrolled infection.
  • Any condition other than heart failure that could limit survival to less than 6 months

Other

  • Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.
  • If of childbearing potential with a positive pregnancy test.
  • Transition to hospice care.
  • Discharge to facility other than acute rehabilitation or to the ambulatory setting.
  • No access to internet or phone.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Inova Fairfax Medical Campus
Coordinator of this site? Confirm its status
Falls ChurchUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.