Bioimpedance Analysis in Chronic Heart Failure

Not Applicable

Suspended

• Conditions: Heart Failure

• Registration Number: NCT02662439
• Lead Sponsor: Peter Studinger

Brief Summary

The aim of this study is to investigate whether the objective measurement of fluid overload by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated heart failure would improve the diuretic therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-25
• Study Start: 2016-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Patients with known or newly discovered chronic heart failure admitted to hospital because of the clinical signs of acut cardiac decompensation

Exclusion Criteria

• High level of fatigue (the patient cannot stand on a scale)
• Amputated upper and/or lower limb(s)
• The BCM analysis is not possible technically (e.g. open wounds on the limbs)
• Severe obesity (>130 kg)
• Patients on chronic hemodialysis or peritoneal dialysis
• Severe fluid volume in the transcellular space
• Patients with a unipolar pacemaker whose sensitivity threshold is very low
• Pregnancy, lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Re-hospitalization rate	12 months

Secondary Outcome Measures

Name	Time	Method
All cause mortality	12 months

Trial Locations

Locations (1)

First Department of Medicine, Semmelweis University; 🇭🇺 Budapest, Hungary