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

Heart Failure; With Decompensation Clinical Trial

— SCALE HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288701
• Other study ID #: EKNZ 2017-00845
• Status: Completed
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: September 27, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure; With Decompensation

Intervention

Device:
• Seca 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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of total body water (TBW) in kg	total body water (TBW) in kg will be measured daily	From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.
Primary	Measurement of body weight (BW) in kg	body weight (BW) in kg will be measured daily	From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.
Secondary	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).	From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.