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NCT03373279 · ClinicalTrials.gov registry record
Bioelectrical Impedance Spectroscopy in Heart Transplantation: Tracking Post-Transplant Changes in Body Composition and Correlation With Conventional Preoperative Risk Assessment Modalities
A clinical trial of Heart Transplant Failure and Rejection, sponsored by Baylor Research Institute.
- Completed
- Registry status
- 69
- Enrollment target
- 1
- Study location
NCT03373279: Completed study of Heart Transplant Failure and Rejection, sponsored by Baylor Research Institute.
NCT03373279 is a study of Heart Transplant Failure and Rejection that has completed, run by Baylor Research Institute. The registered enrollment target is 69 participants, below the 197-participant average among 5 other Heart Transplant Failure and Rejection trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03373279, a study of Heart Transplant Failure and Rejection, has completed, sponsored by Baylor Research Institute.
- COMPLETED
- Registry status
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with marginal physiologic reserve, severe frailty, and/or malnutrition may be regarded as unsuitable candidates for advanced cardiac replacement therapies. However, little data exist on precisely which measures are predictive of subsequent adverse events. Assessment of nutritional status and frailty is still largely predicated on crude and obsolete parameters, such as baseline serum albumin level or body mass index (BMI). In this prospective cohort study the investigators will evaluate the use of bio-electrical impedance spectroscopy (BIS) as a measure of body composition and assess the associations with surgical outcomes.
Primary Outcome
BIS-derived elements such as FM and FFM will be compared with standard preoperative variables for correlation of malnutrition assessment and predictability of adverse clinical events such as mortality, primary graft dysfunction, rejection, acute kidney injury, prolonged hospital stay, and hospital readmission. Several measures of nutrition status will be measured including SGA, BMI, tricep skinfolds, midarm muscle circumference, and FFM via BIS. The methods will be compared to determine agreemen
Conditions Studied
Study Locations (1)
Texas
- Baylor University Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2023-12-30 |
What the finished NCT03373279 record still lists
NCT03373279 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 197-participant average among 5 other Heart Transplant Failure and Rejection trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Heart Transplant Failure and Rejection appearing as the primary indexed condition, and to 0 interventions.
NCT03373279 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03373279 about?
NCT03373279 is a clinical study titled "Bioelectrical Impedance Spectroscopy in Heart Transplantation: Tracking Post-Transplant Changes in Body Composition and Correlation With Conventional Preoperative Risk Assessment Modalities". Patients with marginal physiologic reserve, severe frailty, and/or malnutrition may be regarded as unsuitable candidates for advanced cardiac replacement therapies. However, little data exist on precisely which measures are predictive of subsequent adverse events. Assessment of nutritional status an...
What is the current status of trial NCT03373279?
This trial is currently completed. The enrollment target is 69 participants. The study started on 2017-02-01. Estimated completion is 2023-12-30.
What conditions does trial NCT03373279 study?
This clinical trial studies the following conditions: Heart Transplant Failure and Rejection.
Who is sponsoring clinical trial NCT03373279?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03373279 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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