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Completed

NCT Number: NCT03288701

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

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.

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Key information

Conditions

Heart Failure; With Decompensation Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Seca medical Body Composition Analyser 515

Device

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

Primary outcomes

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

    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.

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

  2. Measurement of body weight (BW) in kg

    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.

    body weight (BW) in kg will be measured daily

Secondary outcomes

  1. Measurement of fatty tissue (FT) in kg

    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.

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: SCALE HF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2017
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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