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Device

Hemodynamic Monitoring for Cardiogenic Shock (HALO-Shock Trial)

N/A
Recruiting
Led By Mitchell A Psotka
Research Sponsored by Inova Health Care Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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. 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.
Must not have
Discharge to facility other than acute rehabilitation or to the ambulatory setting.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months and 6 months
Awards & highlights

Summary

This trial looked at whether using a pulmonary artery catheter to monitor hemodynamics after being hospitalized for cardiogenic shock improved patient outcomes.

Who is the study for?
This trial is for adults over 18 with heart failure who experience shortness of breath during mild activity. They must have survived a recent hospital stay due to cardiogenic shock, have internet and phone access, and be able to consent to the study. People with high procedural risks, no home discharge, pregnancy, infection, life expectancy under 6 months or on certain heart support treatments can't join.
What is being tested?
The trial tests if monitoring heart pressure at home using an implanted device called CardioMEMS can help manage medication better after hospitalization for cardiogenic shock compared to usual care without this device.
What are the potential side effects?
Potential side effects may include complications from implanting the device like bleeding or infection and intolerance to antiplatelet therapy which is required post-implantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I get short of breath with light activity, despite my heart's pumping ability.
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I survived a hospital stay for a severe heart condition that caused low blood pressure and organ issues.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was discharged somewhere other than an acute rehab.
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I am using a device or have had a heart transplant to help my heart pump blood.
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I do not have an active, uncontrolled infection.
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I am transitioning to hospice care.
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I cannot tolerate or follow through with antiplatelet therapy for a year after getting a device implanted.
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I do not have any health conditions that could shorten my life to under 6 months, aside from heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hierarchical primary endpoint
Secondary study objectives
Achieved guideline directed medical therapy for heart failure
All-Cause Hospitalization
All-cause mortality
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CardioMEMS Implant GroupExperimental Treatment1 Intervention
Following enrollment, patients randomized 1:1 to post-discharge implantation of the CardioMEMS device will receive that device ≤14 days following discharge from the index hospitalization for Cardiogenic Shock, in addition to local standard of care medical therapy.
Group II: Non-CardioMEMS Implant GroupActive Control1 Intervention
Following enrollment, patients randomized 1:1 to post-discharge standard of care will be treated according to local standard of care medical therapy following their index hospitalization for Cardiogenic Shock.

Find a Location

Who is running the clinical trial?

Inova Health Care ServicesLead Sponsor
72 Previous Clinical Trials
22,343 Total Patients Enrolled
4 Trials studying Heart Failure
5,321 Patients Enrolled for Heart Failure
AbbottIndustry Sponsor
752 Previous Clinical Trials
478,122 Total Patients Enrolled
20 Trials studying Heart Failure
6,023 Patients Enrolled for Heart Failure
Mitchell A PsotkaPrincipal InvestigatorInova Fairfax Medical Campus

Media Library

CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04419480 — N/A
Heart Failure Research Study Groups: CardioMEMS Implant Group, Non-CardioMEMS Implant Group
Heart Failure Clinical Trial 2023: CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization Highlights & Side Effects. Trial Name: NCT04419480 — N/A
CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04419480 — N/A
~15 spots leftby Dec 2026
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