Body Composition Measurements in Chronic Heart Failure
Primary Purpose
Cachexia, Sarcopenia, Body Composition
Status
Unknown status
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
bioelectrical impedance analysis (Bodystat, Quadscan 4000)
dual-energy X-ray absorptiometry (Hologic, Delphi QDR)
hand grip strength
Sponsored by
About this trial
This is an interventional diagnostic trial for Cachexia
Eligibility 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
Sites / Locations
- Hungarian Institute of CardiologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Body composition measurement
Arm Description
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.
Outcomes
Primary Outcome Measures
Compare total body water (TBW) measured with BIA and DXA.
Compare fat mass (FM) measured with BIA and DXA.
Compare fat-free mass (FFM) measured with BIA and DXA.
Compare extracellular mass (ECM) measured with BIA and DXA.
Compare body cell mass (BCM) measured with BIA and DXA.
Secondary Outcome Measures
Evaluate adverse events that are related to study procedure.
Full Information
NCT ID
NCT02686866
First Posted
February 2, 2016
Last Updated
February 16, 2016
Sponsor
Hungarian Institute of Cardiology
1. Study Identification
Unique Protocol Identification Number
NCT02686866
Brief Title
Body Composition Measurements in Chronic Heart Failure
Official Title
Comparing Body Composition Measurements - Bioelectrical Impedance Analysis and Dual-energy X-ray Absorptiometry - in Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hungarian Institute of Cardiology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Feeding optimization and nutritional assessment in patients with severe heart failure are challenging. The reasons are rather complex and many questions have not been answered yet. Unfortunately, no clear and definitive guidelines are available from the big Nutritional Societies - The European Society for Clinical Nutrition and Metabolism (ESPEN), American Society for Parenteral and Enteral Nutrition (ASPEN), British Association for Parenteral and Enteral Nutrition (BAPEN), Society of Critical Care Medicine (SCCM), Canadian Clinical Care Guidelines. However, there are more and more heated debates in Nutritional Conferences and the need of "Heart Failure feeding-guidelines" is urged. Though local and international comprehensive proposals are highly demanded unfortunately these suggestions are still missing. As we mentioned above there are lots of reasons why this nutritional insufficiency persists. Probably one of these reasons is the "splitting" of medical professions hence creating a proper guideline entail many problems and reveal some unsought difficulties such as lack of knowledge.
The nutrition (esp. TPN) primarily is carried out by anaesthetists and in a less extent manner by gastroenterologists. Feeding performed by surgeons, internists, paediatricians etc. is minimal. Cardiologists can play an important role in the field of nutrition. Cardiac patients are losing their weights very easily and their cardiac cachexia is usually not perceived by most of cardiologists. The best conceivable compensation of heart failure is a prerequisite of "nutritional appropriateness" and in most severe cases this compensation is done by cardiologists. Without this compensation and consequently insufficient cardiac output, this "refeeding" seems to be impossible. Cardia cachexia is an absolute contraindication of Heart Transplantation (HTX) and Ventricular Assist Device/Total Artificial Heart (VAD/TAH) implantation. These patients are usually younger than 65 year-of-age, the expected quality of life (QoL) with a transplanted heart is good and according to the international data the rate of survival is acceptable. Moreover, it is a well known phenomenon that the prevention of cardiac cachexia is much easier than its treatment. Sadly, the use of known nutritional scoring systems - Malnutrition Universal Screening Tool (MUST), Short Nutritional Assessment Questionnaire (SNAQ), Nutritional Risk screening (NRS2002), Malnutrition Screening Tool (MST), Subjective Global Assessment (SGA), Mini Nutritional Assessment (MNA) - which work well in other situations, are of limited value or might not be used at all in this patient group. We must emphasize the fact that increasing number of patients suffering in end-stage heart disease (ESHD) can be expected and further specialization within cardiology makes this problem more pronounced. Without this proper compensation appropriate nutrition is often impossible as well as cardiac compensation can be unsuccessful without proper feeding.
The existing recommendations and traditions in gastroenterology and surgery are different hence it seems to be sensible that the formentioned facts may contribute to the lack of proper guidelines. We believe that the elimination of cardiac cachexia is feasible only with special care and in suitable units. In 2014 our ICU patients, who had not previously been eligible for HTX because of their cachexia, were treated according to our "protocol" and all of them reached the minimum desired weight and were transplanted. The postoperative care and recuperation was similar to those who had not been suffered from cachexia before. These results were also similar we found in the literature. According to our experiences cardiac cachexia seems to be manageable. In case of proper nutrition, international cost-benefit analyses showed positive results regarding patients' recovery: less infections and severe sepsis, decreasing number of in-hospital stays, better wound healing and less ventilatory and ICU days.
Summing up we would like to draw the attention for an unsolved problem which exists not only in Hungary but all over the world. The solution of this problem is urgent but seems possible. We think for overcoming this severe condition we have to change our system, we need new guidelines, we need education and we need further research.
The definition of cardiac cachexia is weight loss of 6% or more in at least 6 months. The incidence in CHF patients with NYHA class III/IV is approximately 10% per year. Chronic heart failure patients with cardiac cachexia have a mortality two to three times higher than noncachectic patients. 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 patients to estimate sarcopenia. These methods can determine the different components of the whole body weight. To estimate sarcopenia it is essential to measure fat-free mass (FFM). According to literature dual energy X-ray absorptiometry (DXA) is the gold standard procedure to determine body composition and FFM. The use of DXA is limited in chronic heart failure patients due to low availability and relatively high cost. Bioelectrical impedance analysis (BIA) is a non-invasive, relatively low cost, bedside body composition measurement method. With no radiation exposure it can be repeated multiple times.
Hypothesis:
The BIA method is already validated in healthy patients and in different disease groups. We suppose that it can be used and reliable data can be obtained in chronic heart failure patient population.
Objectives and aims:
Bioelectrical impedance analysis is not approved in extreme body mass index and body fluid ranges. These conditions however may present in chronic heart failure patients. Thus it is essential to validate BIA to the gold standard DXA method which is our primary aim. Patients admitted to Gottsegen György Hungarian Institute of Cardiology with acute decompensation of chronic heart failure will be enrolled in this prospective study. Enrolled participants will undergo body composition measurements with dual-energy X-ray absorptiometry (Hologic, Delphi QDR) and bioelectrical impedance analysis (Bodystat, Quadscan 4000) methods. The main measured parameters - body weight, total body water, fat mass, fat-free mass (lean weight), extracellular mass, body cell mass, resistance, reactance, phase angle, basal metabolic rate - will be registered in database. Statistical analysis of data acquired by the different methods will be performed to validate BIA.
Primary aim:
Verify that bioelectrical impedance analysis can be safely performed in chronic heart failure patients.
Compare body composition values measured with BIA and DXA. Validate the use of BIA in chronic heart failure patient population.
Secondary aim:
To examine if there is a relationship between sarcopenia or any other altered body composition value and other parameters of chronic heart failure (NYHA functional class, biomarkers, echocardiographic values, hand grip test).
Expected results:
Body composition values measured by bioelectric impedance analysis are correlating with DXA values. These results validate the use of BIA in chronic heart failure patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, Sarcopenia, Body Composition
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Body composition measurement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
bioelectrical impedance analysis (Bodystat, Quadscan 4000)
Intervention Type
Device
Intervention Name(s)
dual-energy X-ray absorptiometry (Hologic, Delphi QDR)
Intervention Type
Device
Intervention Name(s)
hand grip strength
Primary Outcome Measure Information:
Title
Compare total body water (TBW) measured with BIA and DXA.
Time Frame
6 month
Title
Compare fat mass (FM) measured with BIA and DXA.
Time Frame
6 month
Title
Compare fat-free mass (FFM) measured with BIA and DXA.
Time Frame
6 month
Title
Compare extracellular mass (ECM) measured with BIA and DXA.
Time Frame
6 month
Title
Compare body cell mass (BCM) measured with BIA and DXA.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Evaluate adverse events that are related to study procedure.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Andreka, MD, PhD
Phone
0036703820470
Email
andreka.peter@kardio.hu
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Takacs, MD
Phone
0036703820324
Email
ptacky@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Andreka, MD, PhD
Organizational Affiliation
Hungarian Institute of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hungarian Institute of Cardiology
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Takacs, MD
Phone
0036703820324
Email
ptacky@gmail.com
First Name & Middle Initial & Last Name & Degree
Peter Takacs, MD
First Name & Middle Initial & Last Name & Degree
Gabor Uzonyi, MD
First Name & Middle Initial & Last Name & Degree
Éva Török
First Name & Middle Initial & Last Name & Degree
Orsolya Balogh, MD
First Name & Middle Initial & Last Name & Degree
Johanna Szkupeny
First Name & Middle Initial & Last Name & Degree
Miklós Tóth, MD, PhD
First Name & Middle Initial & Last Name & Degree
Andréka Péter, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Body Composition Measurements in Chronic Heart Failure
We'll reach out to this number within 24 hrs