Bioimpedance Analysis in Chronic Heart Failure

NCT ID: NCT02662439

Last Updated: 2017-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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BCM group

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.

Group Type EXPERIMENTAL

Body Composition Monitor (BCM)

Intervention Type DEVICE

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

Control group

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.

Group Type PLACEBO_COMPARATOR

Body Composition Monitor (BCM)

Intervention Type DEVICE

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

Interventions

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Body Composition Monitor (BCM)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peter Studinger

OTHER

Sponsor Role lead

Responsible Party

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Peter Studinger

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Peter Studinger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Department of Medicine, Semmelweis University

Locations

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First Department of Medicine, Semmelweis University

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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HF-BCM-15-1

Identifier Type: -

Identifier Source: org_study_id

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