Body Composition Measurements in Chronic Heart Failure
Comparing Body Composition Measurements - Bioelectrical Impedance Analysis and Dual-energy X-ray Absorptiometry - in Chronic Heart Failure
1 other identifier
interventional
35
1 country
1
Brief Summary
Feeding optimization and nutritional assessment in patients with severe heart failure are challenging. The prevalence of cardiac cachexia may be underestimated by simple measurements of body weight and body mass index because many patients show relative reductions in muscle mass despite being of normal overall weight. Body composition measurement can be essential in chronic heart failure (CHF) patients to estimate sarcopenia. Chronic heart failure patients with cardiac cachexia have a mortality two to three times higher than noncachectic patients. Bedside body composition measurements can reveal developing cardiac cachexia hence can be useful in prevention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 2, 2016
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFebruary 22, 2016
February 1, 2016
5 months
February 2, 2016
February 16, 2016
Conditions
Outcome Measures
Primary Outcomes (5)
Compare total body water (TBW) measured with BIA and DXA.
6 month
Compare fat mass (FM) measured with BIA and DXA.
6 month
Compare fat-free mass (FFM) measured with BIA and DXA.
6 month
Compare extracellular mass (ECM) measured with BIA and DXA.
6 month
Compare body cell mass (BCM) measured with BIA and DXA.
6 month
Secondary Outcomes (1)
Evaluate adverse events that are related to study procedure.
6 month
Study Arms (1)
Body composition measurement
EXPERIMENTALAll patients will undergo body composition measurement with dual-energy X-ray absorptiometry and bioelectrical impedance analysis methods. Hand grip strength will also be performed.
Interventions
Eligibility Criteria
You may qualify if:
- Chronic heart failure (NYHA III-IV)
- Hospitalization for acute decompensation
- Willing to participate
You may not qualify if:
- Unstable hemodynamic status
- Iv. inotropic, vasopressor support
- Severe orthopnea
- Pacemaker, implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT)
- High fever
- Contrast agent administration within 1 week
- Females with childbearing potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hungarian Institute of Cardiology
Budapest, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Andreka, MD, PhD
Hungarian Institute of Cardiology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, FESC
Study Record Dates
First Submitted
February 2, 2016
First Posted
February 22, 2016
Study Start
January 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
February 22, 2016
Record last verified: 2016-02