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

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ClinicalTrials.gov Identifier: NCT03373279
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Study Description
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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
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 Design
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Study Type : Observational
Estimated 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 : February 1, 2017
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. BIS Parameters Predictive of Adverse Outcomes [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving a heart transplant
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373279


Contacts
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Contact: Horacio Martinez, BS, CCRC 214-820-0338 Horacio.Martinez@BSWHealth.org
Contact: Lesia Parker 214-794-6049 Lesia.Parker@BSWHealth.org

Locations
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United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Joost Felius, PhD    214-818-8943    Joost.Felius@BSWHealth.org   
Contact: Yasmeen Akhtar, MS    214-820-1821    Yasmeen.Akhtar@BSWHealth.org   
Principal Investigator: Jeanette Hasse, RD, LD, FADA, CNSC         
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Jeaette Hasse, RD, LD, FADA, CNSC Baylor Health Care System
More Information
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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03373279    
Other Study ID Numbers: 016-114
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baylor Research Institute:
Heart Transplant