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

University Hospital Basel logo

University Hospital Basel

Status

Completed

Conditions

Heart Failure; With Decompensation

Treatments

Device: Seca medical Body Composition Analyser 515

Study type

Interventional

Funder types

Other

Identifiers

NCT03288701
EKNZ 2017-00845

Details and patient eligibility

About

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.

Full 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).

Enrollment

153 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

153 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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