Examining heart tissue and blood in patients with severe heart disease
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease, Effects of Mechanical Unloading on Myocardial Function and Structure in Humans
This study collects heart tissue and blood samples from patients with severe heart disease to learn more about heart failure and compare them with samples from healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 3 sites (Murray, Utah and 2 other locations) |
| Trial ID | NCT01099982 on ClinicalTrials.gov |
What this trial studies
This observational study collects tissue and serum samples from patients with advanced heart disease who are undergoing left ventricular assist device (LVAD) implantation or heart transplantation. The goal is to gather functional, structural, and molecular data to better understand heart failure. Additionally, samples from healthy controls will be used for comparison. The study does not involve any investigational treatments or procedures, focusing solely on data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with heart failure who are undergoing LVAD implantation or heart transplantation.
Not a fit: Patients who do not understand spoken English or are unwilling to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could enhance our understanding of heart disease and improve future treatment strategies for patients with heart failure.
How similar studies have performed: Other studies have successfully utilized similar approaches to gather data on heart disease, indicating potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 years of age diagnosed with heart failure undergoing either LVAD implantation or heart transplantation * 13 to 18 years of age, specifically, older children with heart failure whose body mass index is large enough to accommodate and LVAD Exclusion Criteria: * Neither patient nor patient representative understands spoken English * Neither patient nor patient's personal representative is willing to give written consent for participation.
Where this trial is running
Murray, Utah and 2 other locations
- Intermountain Medical Center — Murray, Utah, United States (Recruiting)
- University of Utah Health Sciences Center — Salt Lake City, Utah, United States (Recruiting)
- VA Salt Lake City Health Care System — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Stavros Drakos, M.D., Ph.D. — University of Utah Health Sciences Center & VA Salt Lake City Health Care System
- Study coordinator: John Kirk
- Email: john.kirk@hsc.utah.edu
- Phone: 801-585-2944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.