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

Heart Transplant Failure and Rejection Clinical Trial

— BIS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03373279
• Other study ID #: 016-114
• Status: Active, not recruiting
• Start date: February 1, 2017
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2023
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 69
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplant Failure and Rejection

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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