Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04419480

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Led by Inova Health Care Services · Updated on 2026-03-16

40

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

Sponsors

I

Inova Health Care Services

Lead Sponsor

A

Abbott

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject or legal representative has signed informed consent and the patient can complete study questionnaires
  • Age 18 years or older
  • NYHA Class III heart failure with dyspnea on mild physical activity
  • Survived current hospitalization for cardiogenic shock defined by low blood pressure or need for catecholamines with evidence of end-organ dysfunction
  • Has internet and phone access for device communication
Not Eligible

You will not qualify if you...

  • High procedural risk due to technical obstacles
  • Receiving ongoing mechanical circulatory support like LVAD or heart transplant during current cardiogenic shock hospitalization
  • Positive pregnancy test if of childbearing potential
  • Transition to hospice care
  • Cannot tolerate or adhere to antiplatelet therapy for 1 year after device implantation
  • Active uncontrolled infection
  • Any condition other than heart failure limiting survival to less than 6 months
  • Discharged to a facility other than acute rehabilitation or ambulatory setting
  • No access to internet or phone

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Inova Fairfax Medical Campus

Falls Church, Virginia, United States, 22042

Actively Recruiting

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Research Team

S

Shashank Sinha, MD MSc

CONTACT

B

Bhruga Shah, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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