Bioelectrical Impedance Spectroscopy in Heart Transplantation: Tracking Post-Transplant Changes in Body Composition and Correlation With Conventional Preoperative Risk Assessment Modalities (BIS)

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.

Study Overview

• Status: Completed
• Conditions: Heart Transplant Failure and Rejection

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.

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving a heart transplant

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIS Parameters Predictive of Adverse Outcomes	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 agreement among the methods in determining malnutrition. In addition, nutrition status measures will be repeated at specified times over the first year following heart transplantation to describe the changes in body composition after transplantation. These changes occur gradually and thus the initial postoperative measurement will be closely representative of the patient's initial (pre-transplant) baseline status.	5 years

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Jeaette Hasse, RD, LD, FADA, CNSC, Baylor Health Care System

Publications and helpful links

General Publications

• Hasse JM, van Zyl JS, Felius J, Lima B, Jamil AK, Alam A. Bioimpedance Spectroscopy in Heart Transplantation: Posttransplant Changes in Body Composition and Effects in Outcomes. Transplantation. 2023 Nov 1;107(11):e305-e317. doi: 10.1097/TP.0000000000004678. Epub 2023 Jun 9.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Heart Transplant
• Additional Relevant MeSH Terms: Behavior; Social Behavior; Rejection, Psychology
• Other Study ID Numbers: 016-114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No