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Body Composition Measurements in Chronic Heart Failure

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ClinicalTrials.gov Identifier: NCT02686866
Recruitment Status : Unknown
Verified February 2016 by ANDREKA PETER, Hungarian Institute of Cardiology.
Recruitment status was:  Recruiting
First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
ANDREKA PETER, Hungarian Institute of Cardiology

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.

Condition or disease Intervention/treatment Phase
Cachexia Sarcopenia Body Composition Device: bioelectrical impedance analysis (Bodystat, Quadscan 4000) Device: dual-energy X-ray absorptiometry (Hologic, Delphi QDR) Device: hand grip strength Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparing Body Composition Measurements - Bioelectrical Impedance Analysis and Dual-energy X-ray Absorptiometry - in Chronic Heart Failure
Study Start Date : January 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
Experimental: Body composition measurement
All patients will undergo body composition measurement with dual-energy X-ray absorptiometry and bioelectrical impedance analysis methods. Hand grip strength will also be performed.
Device: bioelectrical impedance analysis (Bodystat, Quadscan 4000)
Device: dual-energy X-ray absorptiometry (Hologic, Delphi QDR)
Device: hand grip strength



Primary Outcome Measures :
  1. Compare total body water (TBW) measured with BIA and DXA. [ Time Frame: 6 month ]
  2. Compare fat mass (FM) measured with BIA and DXA. [ Time Frame: 6 month ]
  3. Compare fat-free mass (FFM) measured with BIA and DXA. [ Time Frame: 6 month ]
  4. Compare extracellular mass (ECM) measured with BIA and DXA. [ Time Frame: 6 month ]
  5. Compare body cell mass (BCM) measured with BIA and DXA. [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Evaluate adverse events that are related to study procedure. [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic heart failure (NYHA III-IV)
  • Hospitalization for acute decompensation
  • Willing to participate

Exclusion Criteria:

  • 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

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): NCT02686866


Contacts
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Contact: Peter Andreka, MD, PhD 0036703820470 andreka.peter@kardio.hu
Contact: Peter Takacs, MD 0036703820324 ptacky@gmail.com

Locations
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Hungary
Hungarian Institute of Cardiology Recruiting
Budapest, Hungary
Contact: Peter Takacs, MD    0036703820324    ptacky@gmail.com   
Principal Investigator: Peter Takacs, MD         
Sub-Investigator: Gabor Uzonyi, MD         
Sub-Investigator: Éva Török         
Sub-Investigator: Orsolya Balogh, MD         
Sub-Investigator: Johanna Szkupeny         
Sub-Investigator: Miklós Tóth, MD, PhD         
Principal Investigator: Andréka Péter, MD, PhD         
Sponsors and Collaborators
Hungarian Institute of Cardiology
Investigators
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Principal Investigator: Peter Andreka, MD, PhD Hungarian Institute of Cardiology

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Responsible Party: ANDREKA PETER, MD, PhD, FESC, Hungarian Institute of Cardiology
ClinicalTrials.gov Identifier: NCT02686866     History of Changes
Other Study ID Numbers: 101568/2015/OTIG
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Sarcopenia
Heart Failure
Cachexia
Heart Diseases
Cardiovascular Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight