Smart SCALEs With Bioimpedance Analysis for Treatment Guidance in Decompensated Heart Failure
SCALE HF
SCALE HF - Smart SCALEs With Bioelectrical Impedance Analysis for Treatment Guidance in Decompensated Heart Failure
1 other identifier
interventional
153
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2017
CompletedStudy Start
First participant enrolled
September 4, 2017
CompletedFirst Posted
Study publicly available on registry
September 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2019
CompletedMarch 25, 2020
March 1, 2020
2.1 years
July 25, 2017
March 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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 Outcomes (1)
Measurement of fatty tissue (FT) in kg
From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.
Study Arms (1)
Body Composition Analysis
EXPERIMENTALDaily measurement of the Body Composition using electrical Bioimpedance Analysis in a scale (seca mBCA 515). Including total body water and weight.
Interventions
Comparison of reduction of whole body water and body weight in patients with decompensated heart failure under forced diuretic treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel
Basel, Canton of Basel-City, 4031, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Eckstein, MD, PhD
University Hospital, Basel, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2017
First Posted
September 20, 2017
Study Start
September 4, 2017
Primary Completion
September 27, 2019
Study Completion
September 27, 2019
Last Updated
March 25, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share