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With LV Unloading for Cardiogenic Shock

Phase 2

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hospital discharge up to 6 months

Awards & highlights

Study Summary

This trial aims to compare the use of a heart assist device called veno-arterial extracorporeal membrane oxygenation (VA ECMO) with or without an additional device to help the heart

Who is the study for?

This trial is for patients with non-postoperative cardiogenic shock, a severe heart condition where the heart can't pump enough blood. Participants must be receiving veno-arterial extracorporeal membrane oxygenation (VA ECMO) treatment.Check my eligibility

What is being tested?

The study compares two approaches: one group receives VA ECMO alone, while the other gets VA ECMO plus left ventricular unloading using an intra-aortic balloon pump (IABP). The effects on heart and lung function will be measured through lab tests, echocardiography, and pulmonary artery catheter data.See study design

What are the potential side effects?

Potential side effects include complications related to IABP like bleeding or vascular issues, infection risk from additional invasive procedures, and possible impact on organ function due to changes in circulatory support.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hospital discharge up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hospital discharge up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and hospital discharge up to 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

Change in pulmonary capillary wedge pressure

Secondary outcome measures

Cardiac BIN1

Change in N-terminal pro b-type natriuretic peptide

Change in left ventricular end diastolic diameter

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: With LV UnloadingExperimental Treatment1 Intervention

Patients on VA ECMO who randomize to receive LV unloading

Group II: Without LV UnloadingActive Control1 Intervention

Patients on VA ECMO who randomize to receive no LV unloading

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IABP

2009

N/A

~160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MinnesotaOTHER

1,381 Previous Clinical Trials

1,551,180 Total Patients Enrolled

University of UtahLead Sponsor

1,102 Previous Clinical Trials

1,779,157 Total Patients Enrolled

Frequently Asked Questions

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

Is the recruitment phase of this clinical trial still ongoing?

"As per clinicaltrials.gov, this investigation is actively seeking eligible participants. Initial registration for the trial was on April 15th, 2024, with the most recent update conducted on March 27th of the same year."

Answered by AI

What is the safety profile of With LV Unloading in individuals?

"Our team at Power has rated the safety of With LV Unloading as 2 on a scale of 1 to 3. This is due to it being a Phase 2 trial, where some data supports safety but efficacy data is lacking."

Answered by AI

What is the current number of participants being recruited for this clinical study?

"Indeed, information on clinicaltrials.gov shows that this specific research study is actively seeking participants. The trial was originally listed on April 15, 2024, and the most recent update was made on March 27, 2024. There is a need to recruit a total of 104 patients from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Physiology of Unloading VA ECMO Trial

Joseph Tonna 2024. "Physiology of Unloading VA ECMO Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06336655.

All > Ecmo