Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03373279 |
Other study ID # |
016-114 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 1, 2017 |
Est. completion date |
December 30, 2023 |
Study information
Verified date |
January 2023 |
Source |
Baylor Research Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
This is a prospective cohort study, with study visits at Enrollment and subsequently at ≤10
days , 1 month (+/- 7 days), 3 months (+/- 7 days) , 6 months (+/- 14 days) , and 12 months
(+/- 14 days) after heart transplant surgery.
BIS measurements will be performed on patients both in the pretransplant and post-transplant
periods except when contraindicated in the pretransplant setting concerning patients with
advanced heart failure. Because the use of BIS is contraindicated in the setting of permanent
pacemaker and/or internal cardiac defibrillator (ICD) devices, BIS assessment cannot be
performed in the pretransplant setting for patients with advanced heart failure as the
majority of these patients already have these devices in place. However, at the time of
cardiac transplantation, these devices will be removed from those patients with advanced
heart failure and the BIS measurements will then be performed shortly after transplantation,
and then serially during the post-transplant period at various time intervals for one year in
order to track changes in body composition.
These measurements will be compared to traditional measurements performed at the time of
preoperative evaluation by the nutritional and dietitian support team.