Clinical trial NCT03373279: Bioelectrical Impedance Spectroscopy in Heart Transplantation: Tracking Post-Transplant Changes in Body Composition and Correlation With Conventional Preoperative Risk Assessment Modalities
Official title: Bioelectrical Impedance Spectroscopy in Heart Transplantation: Tracking Post-Transplant Changes in Body Composition and Correlation With Conventional Preoperative Risk Assessment Modalities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Transplant Failure and Rejection
Keywords: Heart Transplant
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving a heart transplant

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: BIS Parameters Predictive of Adverse Outcomes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Jeaette Hasse, RD, LD, FADA, CNSC
role: PRINCIPAL_INVESTIGATOR
References: