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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03288701
Acronym
SCALE HF
Enrollment
153
Registered
2017-09-20
Start date
2017-09-04
Completion date
2019-09-27
Last updated
2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure; With Decompensation

Keywords

heart failure, cardial decompensation, smart scale, bioimpedance analysis, whole body water

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).

Interventions

DEVICESeca 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

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.)

Design outcomes

Primary

MeasureTime frameDescription
Measurement of total body water (TBW) in kgFrom 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 kgFrom 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

MeasureTime frameDescription
Measurement of fatty tissue (FT) in kgFrom 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).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026