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Bioimpedance Analysis in Chronic Heart Failure

Role of the Bioimpedance Analysis in Guiding the Diuretic Therapy in Chronic Heart Failure - A Randomized Controlled Trial

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02662439
Enrollment
240
Registered
2016-01-25
Start date
2016-02-29
Completion date
Unknown
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Bioimpedance analysis, Fluid overload

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.

Interventions

In the experimental group, the diuretic therapy adjusted according to the result of the BCM analysis.

Sponsors

Peter Studinger
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Re-hospitalization rate12 months

Secondary

MeasureTime frame
All cause mortality12 months

Other

MeasureTime frameDescription
Quality of life3 monthsMeasured by validated questionnaire
Renal function decline3 monthsMeasured by estimated glomerular filtration rate (ml/min/1.73m2)

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026