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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am diagnosed with heart failure and will get an LVAD before a transplant.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Left Ventricular Ejection Fraction (LVEF)
Secondary outcome measures
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 moreTrial 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
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Who is running the clinical trial?
STAVROS G DRAKOSLead Sponsor
2 Previous Clinical Trials
510 Total Patients Enrolled
1 Trials studying Heart Failure
10 Patients Enrolled for Heart Failure
American Heart AssociationOTHER
320 Previous Clinical Trials
4,932,388 Total Patients Enrolled
30 Trials studying Heart Failure
137,529 Patients Enrolled for Heart Failure
Stavros Drakos, MDPrincipal InvestigatorUniversity of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I or my representative do not understand spoken English.I am diagnosed with heart failure and will get an LVAD before a transplant.I was not hospitalized due to side effects during the initial treatment phase.
Research Study Groups:
This trial has the following groups:- Group 1: Controlled Cardiac Reloading
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any fresh participants being invited to join this trial?
"Affirmative. Clinicaltrials.gov indicates that this medical trial, which was originally posted on June 23rd 2017 and recently updated on June 15th 2022 is recruiting patients. The research team intends to enrol 100 people at one site."
Answered by AI
What is the current sample size of participants in this trial?
"Affirmative. According to clinicaltrials.gov, this research endeavour is still looking for participants who meet the criteria; it was first posted on June 23rd 2017 and most recently updated on June 15th 2022. The trial requires 100 individuals from a single site for its completion."
Answered by AI
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