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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT03288701

Collaborator

(none)

153

Enrollment

Location

Arm

24.7

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; With Decompensation	Device: Seca medical Body Composition Analyser 515	N/A

Detailed Description

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

153 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 4, 2017

Actual Primary Completion Date :

Sep 27, 2019

Actual Study Completion Date :

Sep 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Body Composition Analysis 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 Comparison of reduction of whole body water and body weight in patients with decompensated heart failure under forced diuretic treatment

Arm

Intervention/Treatment

Experimental: Body Composition Analysis

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

Comparison of reduction of whole body water and body weight in patients with decompensated heart failure under forced diuretic treatment

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Measurement of fatty tissue (FT) in kg [From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.)