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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months and 6 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met