CClinicalTrials.gg
CompletedNCT03288701SCALE HFUpdated Mar 25, 2020

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

An interventional study of Seca medical Body Composition Analyser 515 in Heart Failure; With Decompensation, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-25.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
153
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Heart Failure; With Decompensation

Browse trials for

Keywords

  • heart failure
  • cardial decompensation
  • smart scale
  • bioimpedance analysis
  • whole body water
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.)
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
153 participants (actual)

Study arms

  • 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

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

05

What researchers measure

Primary outcomes

  1. Measurement of total body water (TBW) in kg

    total body water (TBW) in kg will be measured daily

    Time frame: From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.

  2. Measurement of body weight (BW) in kg

    body weight (BW) in kg will be measured daily

    Time frame: From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.

Secondary outcomes

  1. 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).

    Time frame: From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.

06

Study locations

1 site
  • University Hospital Basel
    Basel, BS 4031, Switzerland
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03288701
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Sep 20, 2017
Start date
Sep 4, 2017
Primary completion
Sep 27, 2019
Completion
Sep 27, 2019
Last update
Mar 25, 2020

Study contacts

Jens Eckstein, MD, PhD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion