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Device

Hemodynamic Monitoring for Cardiogenic Shock (HALO-Shock Trial)

N/A

Recruiting

Led By Shashank Sinha, MD MSc

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months and 6 months

Awards & highlights

HALO-Shock Trial 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.Check my eligibility

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.See study design

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.

HALO-Shock Trial 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.

HALO-Shock Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hierarchical primary endpoint

Secondary outcome measures

Achieved guideline directed medical therapy for heart failure

All-Cause Hospitalization

All-cause mortality

+5 more

HALO-Shock 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Inova Health Care ServicesLead Sponsor

69 Previous Clinical Trials

22,215 Total Patients Enrolled

3 Trials studying Heart Failure

5,170 Patients Enrolled for Heart Failure

AbbottIndustry Sponsor

751 Previous Clinical Trials

478,135 Total Patients Enrolled

20 Trials studying Heart Failure

6,023 Patients Enrolled for Heart Failure

Shashank Sinha, MD MScPrincipal 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open recruitment opportunities for this experimental research?

"Affirmative. According to the information sourced from clinicaltrials.gov, this medical trial is presently seeking participants - first registered on December 31st 2020 and last amended December 3rd 2021. 40 subjects are required at a single location."

Answered by AI

How many people have enrolled in the experiment thus far?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial is actively recruiting, with a posting date of December 31st 2020 and the most recent update occurring on December 3rd 2021. 40 participants are required from 1 particular location for successful completion of the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Mitchell Psotka, MD, Ph.D 2020. "Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04419480.

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