Bioimpedance Analysis in Chronic Heart Failure
Not Applicable
Suspended
- Conditions
- Heart Failure
- Interventions
- Device: Body Composition Monitor (BCM)
- 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
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
- Arm && Interventions
Group Intervention Description BCM group Body Composition Monitor (BCM) The patients are measured by Body Composition Monitor (BCM) and both the patient and the physician know the results and adjust the diuretic therapy accordingly. Control group Body Composition Monitor (BCM) The patients are measured by Body Composition Monitor (BCM) but neither the patient nor the physician know the results, the physician adjusts the diuretic therapy as usual, according to the protocols.
- 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