CachexiaPhase 4NCT02686866
Body Composition Measurements in Chronic Heart Failure
A Phase 4 study testing bioelectrical impedance analysis (Bodystat, Quadscan 4000), dual-energy X-ray absorptiometry (Hologic, Delphi QDR) and hand grip strength in people with Cachexia and Sarcopenia, run by Hungarian Institute of Cardiology at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, Sarcopenia, Body Composition
- What is being tested?
- bioelectrical impedance analysis (Bodystat, Quadscan 4000), dual-energy X-ray absorptiometry (Hologic, Delphi QDR) and hand grip strength
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteHungary
- Study dates
- Jan 2016to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure (NYHA III-IV)
- Hospitalization for acute decompensation
- Willing to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Hungarian Institute of Cardiology
Budapest
Peter Takacs, MD, 0036703820324, ptacky@gmail.com
Peter Takacs, MD
About this study
Official title: Comparing Body Composition Measurements - Bioelectrical Impedance Analysis and Dual-energy X-ray Absorptiometry - in Chronic Heart Failure
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.
Read the 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.
- Conditions
- Cachexia, Sarcopenia, Body Composition
- Being tested
- bioelectrical impedance analysis (Bodystat, Quadscan 4000), dual-energy X-ray absorptiometry (Hologic, Delphi QDR), hand grip strength
- Medical subject headings
- Cachexia, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioelectrical impedance analysis (Bodystat, Quadscan 4000)Device
dual-energy X-ray absorptiometry (Hologic, Delphi QDR)Device
hand grip strengthDevice
| Study group | Role | What they receive |
|---|---|---|
| Body composition measurement | Experimental | 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. Receives: Device: bioelectrical impedance analysis (Bodystat, Quadscan 4000); Device: dual-energy X-ray absorptiometry (Hologic, Delphi QDR); Device: hand grip strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare total body water (TBW) measured with BIA and DXA.
Measured: 6 month
Compare fat mass (FM) measured with BIA and DXA.
Measured: 6 month
Compare fat-free mass (FFM) measured with BIA and DXA.
Measured: 6 month
Compare extracellular mass (ECM) measured with BIA and DXA.
Measured: 6 month
Compare body cell mass (BCM) measured with BIA and DXA.
Measured: 6 month
Secondary outcomes (1)
Evaluate adverse events that are related to study procedure.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hungarian Institute of Cardiology
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ANDREKA PETER, Hungarian Institute of Cardiology
- Investigators
- Peter Andreka, MD, PhD, Principal investigator, Hungarian Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686866
- Sponsor's protocol ID
- 101568/2015/OTIG
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2016
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Body Composition Measurements - Bioelectrical Impedance Analysis and Dual-energy X-ray Absorptiometry - in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02686866
- Acronym / sponsor ID
- 101568/2015/OTIG
- Conditions
- Cachexia, Sarcopenia, Body Composition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Hungarian Institute of CardiologyOther government
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body composition measurement | Experimental | Device: bioelectrical impedance analysis (Bodystat, Quadscan 4000), Device: dual-energy X-ray absorptiometry (Hologic, Delphi QDR), Device: hand grip strengthAll patients will undergo body composition measurement with dual-energy X-ray absorptiometry and bioelectrical impedance analysis methods. Hand grip strength will also be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic heart failure (NYHA III-IV)
- Hospitalization for acute decompensation
- Willing to participate
Key exclusion criteria (7 listed)
- Unstable hemodynamic status
- Iv. inotropic, vasopressor support
- Severe orthopnea
- Pacemaker, implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT)
- High fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioelectrical impedance analysis (Bodystat, Quadscan 4000) | Device | Body composition measurement |
| dual-energy X-ray absorptiometry (Hologic, Delphi QDR) | Device | Body composition measurement |
| hand grip strength | Device | Body composition measurement |
Primary outcome
Compare total body water (TBW) measured with BIA and DXA.
Time frame: 6 month
Compare fat mass (FM) measured with BIA and DXA.
Time frame: 6 month
Compare fat-free mass (FFM) measured with BIA and DXA.
Time frame: 6 month
Compare extracellular mass (ECM) measured with BIA and DXA.
Time frame: 6 month
Compare body cell mass (BCM) measured with BIA and DXA.
Time frame: 6 month
1 secondary outcome
Evaluate adverse events that are related to study procedure.
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Andreka, MD, PhD principal investigator
Hungarian Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bioelectrical impedance analysis (Bodystat, Quadscan 4000), dual-energy X-ray absorptiometry (Hologic, Delphi QDR) and hand grip strength in people with Cachexia and Sarcopenia, run by Hungarian Institute of Cardiology at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Andreka, MD, PhD (0036703820470, andreka.peter@kardio.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare total body water (TBW) measured with BIA and DXA. (time frame: 6 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.