Metabolic Study for Heart Failure

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: AdventHealth Translational Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how metabolism changes in people with heart failure. Researchers will collect discarded heart tissue from patients undergoing heart-related surgeries, such as valve repair or heart transplants. Individuals with chronic heart failure scheduled for these procedures might be suitable candidates. The study does not test a new treatment but seeks to expand knowledge about heart failure. As an unphased trial, it offers patients the opportunity to contribute to valuable research that could enhance future heart failure treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the collection of discarded heart tissue is safe?

In this study, researchers use leftover heart tissue from surgeries such as heart transplants or valve repairs. Since the research utilizes tissue already removed, no direct treatment is given to patients. Consequently, there are no safety concerns or side effects for participants, as their treatment plans remain unchanged. Participants simply allow their leftover tissue to be used for research once it is no longer needed. Therefore, the study poses no additional risks to patients.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on collecting discarded heart tissue, offering a unique way to study heart failure. Unlike typical treatments that aim to manage symptoms or improve heart function, this approach allows scientists to directly examine heart tissue at a cellular level. By doing so, they hope to uncover new insights into the metabolic processes involved in heart failure, potentially leading to more targeted and effective treatments in the future. This innovative method could pave the way for breakthroughs that current treatments, like medications or surgical interventions, might not achieve on their own.

What evidence suggests that this trial's methods could be effective for understanding heart failure?

This trial focuses on collecting discarded heart tissue, not testing a new treatment. The goal is to understand how changes in metabolism, the body's process of turning food into energy, can lead to heart failure. Studies have shown that metabolism plays a crucial role in heart health. By examining heart tissue, researchers aim to uncover clues about the mechanisms of heart failure, potentially aiding in the development of future treatments.

Who Is on the Research Team?

RE

Richard E Pratley, MD

Principal Investigator

Translational Research Institute for Metabolism and Diabetes

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subjects are capable of giving informed consent
You are between 19 and 89 years old.
You have been diagnosed with chronic heart failure.
See 3 more

Exclusion 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.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo cardiac surgery, including LVAD implantation, heart transplant, valve replacement or repair, endomyocardial biopsy, or arterial bypass surgery. Tissue samples are collected during surgery.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Collection of discarded heart tissue
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Cardiac surgeryExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AdventHealth Translational Research Institute

Lead Sponsor

Trials
51
Recruited
5,900+

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials
41
Recruited
3,600+

Florida Hospital Cardiovascular Institute

Collaborator

Trials
1
Recruited
60+

Sanford-Burnham Medical Research Institute

Collaborator

Trials
9
Recruited
770+

Published Research Related to This Trial

The Heart Failure Collaboratory developed a streamlined case report form (CRF) for heart failure clinical trials, reducing the number of data items from 176 to 75 baseline items and 6 events, which aims to improve trial efficiency and reduce administrative burdens.
This new consensus CRF, created with input from various stakeholders including patients and the FDA, is designed to enhance data compatibility across trials, ultimately improving the integrity of evidence collected in heart failure device development.
Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development.Psotka, MA., Fiuzat, M., Carson, PE., et al.[2020]

Citations

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