← Back to Search

Device

LVAD Conditioning for Heart Failure

N/A

Recruiting

Led By Stavros Drakos, MD

Research Sponsored by STAVROS G DRAKOS

Eligibility Criteria Checklist

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

Must have

Diagnosed with heart failure undergoing LVAD implantation as a bridge to transplant

Be older than 18 years old

Must not have

Neither the subject nor the subject's representative understands spoken English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (lvad implantation) and at time of lvad explantation/heart transplantation (up to 12 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether myocardial conditioning can improve heart function in end-stage heart failure patients supported by an LVAD.

Who is the study for?

This trial is for heart failure patients who are getting an LVAD implant as a temporary step before a transplant. They must be part of another study (IRB 30622) and able to give consent. People who don't understand English or have been hospitalized due to complications during earlier treatment phases cannot join.

What is being tested?

The study tests if adjusting the speed of the LVAD can help improve heart function by gradually increasing the heart's workload. This method, known as myocardial conditioning, could potentially enhance quality of life for those with severe heart failure.

What are the potential side effects?

While specific side effects aren't listed, reducing LVAD speed may increase risks such as strain on the failing heart, which could lead to worsening symptoms or other complications related to insufficient cardiac support.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am diagnosed with heart failure and will get an LVAD before a transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I or my representative do not understand spoken English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (lvad implantation) and at time of lvad explantation/heart transplantation (up to 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (lvad implantation) and at time of lvad explantation/heart transplantation (up to 12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (lvad implantation) and at time of lvad explantation/heart transplantation (up to 12 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

Change in Left Ventricular Ejection Fraction (LVEF)

Secondary study objectives

Change in Left Ventricular End Diastolic Diameter (LVEDD)

Change in Left Ventricular End Diastolic Volume (LVEDV)

Change in Left Ventricular End Systolic Diameter (LVESD)

+13 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Controlled Cardiac ReloadingExperimental Treatment1 Intervention

Heart failure patients with recent LVAD implantation after an optimum unloading phase, will undergo controlled cardiac reloading through LVAD speed adjustment reductions in a controlled reloading phase

0 / 2Eligibility criteria met