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

Sponsor
Baylor Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03373279
Collaborator
(none)
70
1
67.9
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Bioelectrical Impedance Spectroscopy in Heart Transplantation: Tracking Post-Transplant Changes in Body Composition and Correlation With Conventional Preoperative Risk Assessment Modalities
    Actual Study Start Date :
    Feb 1, 2017
    Anticipated Primary Completion Date :
    Feb 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. BIS Parameters Predictive of Adverse Outcomes [5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baylor University Medical Center Dallas Texas United States 75246

    Sponsors and Collaborators

    • Baylor Research Institute

    Investigators

    • Principal Investigator: Jeaette Hasse, RD, LD, FADA, CNSC, Baylor Health Care System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baylor Research Institute
    ClinicalTrials.gov Identifier:
    NCT03373279
    Other Study ID Numbers:
    • 016-114
    First Posted:
    Dec 14, 2017
    Last Update Posted:
    Jul 30, 2020
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Baylor Research Institute

    Study Results

    No Results Posted as of Jul 30, 2020