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Congestive Heart Failure · Observational Study
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned observational registry study enrolling approximately 300 end-stage heart failure patients undergoing LVAD implantation or heart transplantation to collect and analyze myocardial tissue and serum samples. No results are reported in this registry record; the study aims to characterize functional, structural, and molecular aspects of heart failure using stored biological samples and will not immediately influence individual patient treatment.
Observational. Congestive Heart Failure; age from 13 Years. Intervention: Advanced Heart Failure Therapy Group; Normal Hearts Group. Compared with: Healthy control samples from unused donor grafts. n = 300. 3 sites: United States.
This is a planned observational registry study enrolling approximately 300 end-stage heart failure patients undergoing LVAD implantation or heart transplantation to collect and analyze myocardial tissue and serum samples. No results are reported in this registry record; the study aims to characterize functional, structural, and molecular aspects of heart failure using stored biological samples and will not immediately influence individual patient treatment.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
No clinical impact can be assessed from this registry record, as no results are reported. This study is designed to generate a database of myocardial tissue and serum samples for future research investigations into the biology of heart failure; findings from this resource may inform future mechanistic and clinical studies.
This is a registry study collecting tissue and serum samples from heart failure patients with planned analysis of myocardial function at baseline and 3 months; no results are reported in this registration record.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed from this registry record, as no results are reported. This study is designed to generate a database of myocardial tissue and serum samples for future research investigations into the biology of heart failure; findings from this resource may inform future mechanistic and clinical studies.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT01099982). This is a study registration, not published results. Lead sponsor: University of Utah. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Congestive Heart Failure. Primary outcome measures: Change in myocardial function , baseline and 3 months. Brief summary: Hypothesis: Tissue and serum samples collected from end-stage heart failure patients receiving left ventricular assist device implantation (LVAD) or heart transplantation will provide information regarding the basic science of heart disease. Tissue and serum samples collected from a limited numbers of "healthy controls" (donor grafts that were not utilized for heart transplantation) will serve as a comparator in research database projects. Design: This is a registry project; there are no investigational treatments, drug or procedures associated with participation in registry activities. This project is an organized functional data and tissue data gathering and storing (database) endeavor with specific focus on the functional, structural, and molecular aspects of heart failure. Data collection will not immediately influence the course of treatment for any patient.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.