Bioelectrical Impedance Spectroscopy in Heart Transplantation: Tracking Post-Transplant Changes in Body Composition and Correlation With Conventional Preoperative Risk Assessment Modalities
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 12/16/2017 |
| Start Date: | February 1, 2017 |
| End Date: | October 2022 |
| Contact: | Horacio Martinez, BS, CCRC |
| Email: | Horacio.Martinez@BSWHealth.org |
| Phone: | 214-820-0338 |
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.
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.
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.
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.
Inclusion Criteria:
- Listed for a native heart transplant at BUMC
- At least 18 years of age
Exclusion Criteria:
- Women during pregnancy
- Patient currently has a ventricular assist device
We found this trial at
1
site
3500 Gaston Avenue
Dallas, Texas 75246
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Jeanette Hasse, RD, LD, FADA, CNSC
Phone: 214-820-0338
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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