Smart SCALEs With Bioimpedance Analysis for Treatment Guidance in Decompensated Heart Failure

Study Overview
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Brief Summary
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In this trial the measurement of whole body water will be compared to the standard method of measuring the body weight as treatment guidance in patients with decompensated heart failure. The Seca mBCA 515 [medical Body Composition Analyser] will be used to quantify the whole body water by using bioelectrical impedance analysis.

Detailed Description
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Investigators will include 153 participants hospitalized in the University Hospital in Basel. Daily measurements of whole body water and body weight will be performed in each person until diuretic treatment is stopped or the patient is discharged from hospital, respectively. Primary endpoint is the correlation between reduction of whole body water (in kg) and reduction of body weight (in kg) in patients with decompensated heart failure receiving forced diuretic treatment (max. deviation +/- 1kg).

Official Title
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SCALE HF - Smart SCALEs With Bioelectrical Impedance Analysis for Treatment Guidance in Decompensated Heart Failure

Conditions
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Heart Failure; With Decompensation

Intervention / Treatment
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* Device: Seca medical Body Composition Analyser 515


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to give informed consent hospitalization because of decompensated heart failure treated with forced diuresis able to stand on the scale without help from others and able to hold handrails with both hands Exclusion Criteria: refusal to share personal data implantable electronic device (e.g. Pacemaker, etc.) condition that does not allow skin contact of soles of feet and scale or hands with handrail (leg prosthesis, wounds, bandage, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Body Composition Analysis<br>Daily measurement of the Body Composition using electrical Bioimpedance Analysis in a scale (seca mBCA 515). Including total body water and weight. | Device: Seca medical Body Composition Analyser 515<br>* Comparison of reduction of whole body water and body weight in patients with decompensated heart failure under forced diuretic treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of total body water (TBW) in kg | total body water (TBW) in kg will be measured daily | From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks. | 
| Measurement of body weight (BW) in kg | body weight (BW) in kg will be measured daily | From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of fatty tissue (FT) in kg | To provide a more exact comparison of total body water and body weight, fatty mass will be subtracted from the body weight. Subsequently the absolute difference between the reduction of the total body water (in kg) and the reduction of the body weight (in kg), in which fatty tissue (in kg) was subtracted, will be calculated (e.g. (BW day 1- FT day 1) - (BW day 2 - FT day 2) = reduction of BW without fatty tissue). | From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, cardial decompensation, smart scale, bioimpedance analysis, whole body water