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

Not Applicable

Completed

• Conditions: Heart Failure; With Decompensation
• Interventions: Device: Seca medical Body Composition Analyser 515

• Registration Number: NCT03288701
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

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 Timeline

• Study First Submitted: 2017-07-25
• Study Start: 2017-09-04
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-20
• Primary Completion: 2019-09-27
• Study Completion: 2019-09-27
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Body Composition Analysis	Seca medical Body Composition Analyser 515	Daily measurement of the Body Composition using electrical Bioimpedance Analysis in a scale (seca mBCA 515). Including total body water and weight.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, BS, Switzerland