Bioimpedance Analysis in Chronic Heart Failure

Peter Studinger

Status: Suspended

Conditions: Heart Failure

Treatments: Device: Body Composition Monitor (BCM)

Study type: Interventional

Funder types: Other

Identifiers

NCT02662439

HF-BCM-15-1

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups, including a placebo group

BCM group

Experimental group

Description:

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.

Treatment:

Device: Body Composition Monitor (BCM)

Control group

Placebo Comparator group

Description:

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.

Treatment:

Device: Body Composition Monitor (BCM)