Metabolic Study for Heart Failure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth Translational Research Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

55 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the research is to help researchers understand changes in metabolism in patients that develop heart failure.

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.

Is the treatment involving discarded heart tissue generally safe for humans?

The research articles focus on the collection and use of human heart tissue for research purposes, but they do not provide specific safety data about treatments derived from this tissue. They discuss protocols for collecting tissue and the importance of human samples in research, but no direct safety information for treatments is mentioned. ^{1 2 3 4 5}

How does this treatment for heart failure differ from existing options?

This treatment is unique because it focuses on addressing the profound metabolic changes in failing hearts, such as the depletion of energy molecules and the defective import of fatty acids, which are not typically targeted by standard heart failure treatments. By potentially improving the heart's energy production and utilization, it offers a novel approach compared to traditional therapies that primarily focus on managing symptoms and preventing fluid buildup. ^{6 7 8 9 10}

Research Team

Richard E Pratley, MD

Principal Investigator

Translational Research Institute for Metabolism and Diabetes

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Cardiac surgery Experimental Treatment 1 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.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development. Psotka, MA., Fiuzat, M., Carson, PE., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Models of cardiovascular surgery biobanking to facilitate translational research and precision medicine. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A Protocol for Collecting Human Cardiac Tissue for Research. [2020]

4. China pubmed.ncbi.nlm.nih.gov

Heart 'omics' in AGEing (HOMAGE): design, research objectives and characteristics of the common database. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The Human Explanted Heart Program: A translational bridge for cardiovascular medicine. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Integrated landscape of cardiac metabolism in end-stage human nonischemic dilated cardiomyopathy. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Energy Metabolites as Biomarkers in Ischemic and Dilated Cardiomyopathy. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Dynamic Metabolic Changes During Prolonged Ex Situ Heart Perfusion Are Associated With Myocardial Functional Decline. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Metabolomic Profiling During Ex-situ Normothermic Perfusion Prior to Heart Transplantation Defines Patterns of Substrate Utilization and Correlates with Markers of Allograft Injury. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Metabolomic analysis of serum and myocardium in compensated heart failure after myocardial infarction. [2020]