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

NCT03373279 | Completed

• 1 other identifier: 016-114
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplant Failure and Rejection

Keywords

Heart Transplant

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving a heart transplant

You may qualify if:

• Listed for a native heart transplant at BUMC
• At least 18 years of age

You may not qualify if:

• Women during pregnancy
• Patient currently has a ventricular assist device

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (1)

• 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.

  PMID: 37291721 DERIVED

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Jeaette Hasse, RD, LD, FADA, CNSC

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 14, 2017
• Study Start: February 1, 2017
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 22, 2026

Record last verified: 2023-01

Locations

US (1)