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CardioMEMS for Cardiogenic Shock and Heart Failure

This study is looking at whether using a device called CardioMEMS can help people who have been hospitalized for cardiogenic shock (a severe form of heart failure where your heart can't pump enough blood). The CardioMEMS device is implanted and helps doctors monitor your pulmonary artery pressure (pressure in the blood vessels leading to your lungs) from home. This monitoring helps doctors adjust your heart failure medications. The study aims to see if this approach can prevent future health problems. You might be able to join if you are 18 or older and have NYHA Class III heart failure, meaning you experience shortness of breath with mild activity. The study will measure success by looking at a main outcome at 6 months. The current status of this study is unclear.

Study design
This is a pilot, prospective, randomized, unblinded, pragmatic trial. It plans to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a primary endpoint measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04419480

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Recruiting
NAAges 18+InterventionalTreatment
Inova Health Care Services
~40 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hierarchical primary endpoint
Measured over 6 months

Conditions

Cardiogenic Shock
Heart Failure
Ambulatory Hemodynamic Monitoring

Explore related trials

Cardiogenic ShockHeart Failure

NCT04419480

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Inova Fairfax Medical Campus

    Falls Church, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Shashank Sinha, MD MSc · PRINCIPAL_INVESTIGATOR · Inova Fairfax Medical Campus

Who to contact

Shashank Sinha, MD MSc
[email protected]
7037764001
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Hierarchical primary endpoint6 months

    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