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Metabolic Study for Heart Failure
N/A
Waitlist Available
Led By Richard E Pratley, MD
Research Sponsored by AdventHealth Translational Research Institute
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 restricted to the time around surgical procedure
Awards & highlights
Summary
This trial will help researchers understand changes in metabolism in patients that develop heart failure.
Who is the study for?
This trial is for adults aged 19-89 with chronic heart failure who can consent to participate. They must be scheduled for certain heart procedures, like LVAD implantation or cardiac transplantation. People with a life expectancy under 2 weeks, severe kidney disease, active infections, substance abuse, or other specific health issues cannot join.Check my eligibility
What is being tested?
Researchers are collecting and studying discarded heart tissue from patients undergoing various heart-related medical procedures. The goal is to understand metabolic changes in those with heart failure.See study design
What are the potential side effects?
Since the intervention involves only the collection of already discarded tissue during surgery and not an active treatment, there are no direct side effects associated with this study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ restricted to the time around surgical procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~restricted to the time around surgical procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Analyses of collected tissues
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cardiac surgeryExperimental Treatment1 Intervention
Subjects will be recruited by a coordinator through electronic medical record (EMR) searches to identify those undergoing left ventricle assist device (LVAD) implantation and explantation, heart transplant, valve replacement or repair, endomyocardial biopsy during catheterization, and arterial bypass surgery. Prior to the procedure, potential subjects will be informed about the clinical study and if interested, they will be consented.
Find a Location
Who is running the clinical trial?
Florida Hospital Cardiovascular InstituteUNKNOWN
AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
5,573 Total Patients Enrolled
Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,566 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not expected to live for more than 2 weeks.You have cancer, severe kidney disease, active infection, liver damage, or alcohol or drug addiction.Your heart has been severely damaged by a heart attack with little healthy heart tissue left.You have a heart condition that makes you unsuitable for organ donation.You are between 19 and 89 years old.You have been diagnosed with chronic heart failure.You are scheduled to have certain heart procedures such as LVAD implantation, heart transplant, valve replacement, or coronary artery bypass graft.Heart samples not suitable for transplant due to recipient issues, evidence of problems after removal, or positive but non-harmful test results.Your medical records show that your heart is working normally.
Research Study Groups:
This trial has the following groups:- Group 1: Cardiac surgery
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.
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