Back to resultsSmart SCALEs With Bioimpedance Analysis for Treatment Guidance in Decompensated Heart Failure (SCALE HF)
Primary Purpose
Heart Failure; With Decompensation
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Seca medical Body Composition Analyser 515
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure; With Decompensation focused on measuring heart failure, cardial decompensation, smart scale, bioimpedance analysis, whole body water
Eligibility Criteria
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.)
Sites / Locations
- University Hospital Basel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Body Composition Analysis
Arm Description
Daily measurement of the Body Composition using electrical Bioimpedance Analysis in a scale (seca mBCA 515). Including total body water and weight.
Outcomes
Primary Outcome Measures
Measurement of total body water (TBW) in kg
total body water (TBW) in kg will be measured daily
Measurement of body weight (BW) in kg
body weight (BW) in kg will be measured daily
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03288701
First Posted
July 25, 2017
Last Updated
March 24, 2020
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT03288701
Brief Title
Smart SCALEs With Bioimpedance Analysis for Treatment Guidance in Decompensated Heart Failure
Acronym
SCALE HF
Official Title
SCALE HF - Smart SCALEs With Bioelectrical Impedance Analysis for Treatment Guidance in Decompensated Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
September 27, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure; With Decompensation
Keywords
heart failure, cardial decompensation, smart scale, bioimpedance analysis, whole body water
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Body Composition Analysis
Arm Type
Experimental
Arm Description
Daily measurement of the Body Composition using electrical Bioimpedance Analysis in a scale (seca mBCA 515). Including total body water and weight.
Intervention Type
Device
Intervention Name(s)
Seca medical Body Composition Analyser 515
Intervention Description
Comparison of reduction of whole body water and body weight in patients with decompensated heart failure under forced diuretic treatment
Primary Outcome Measure Information:
Title
Measurement of total body water (TBW) in kg
Description
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.
Title
Measurement of body weight (BW) in kg
Description
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 Outcome Measure Information:
Title
Measurement of fatty tissue (FT) in kg
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Eckstein, MD, PhD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
State/Province
BS
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Smart SCALEs With Bioimpedance Analysis for Treatment Guidance in Decompensated Heart Failure
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