Bioimpedance Analysis in Chronic Heart Failure

P

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)

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)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems