Bioimpedance Analysis in Chronic Heart Failure

May 31, 2017 updated by: Peter Studinger

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1083
        • First Department of Medicine, Semmelweis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Body Composition Monitor (BCM)
In the experimental group, the diuretic therapy adjusted according to the result of the BCM analysis.
Placebo Comparator: 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.
Device: Body Composition Monitor (BCM)
In the experimental group, the diuretic therapy adjusted according to the result of the BCM analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Re-hospitalization rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 3 months
Measured by validated questionnaire
3 months
Renal function decline
Time Frame: 3 months
Measured by estimated glomerular filtration rate (ml/min/1.73m2)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Studinger

Investigators

  • Principal Investigator: Peter Studinger, MD, PhD, First Department of Medicine, Semmelweis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 25, 2016

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF-BCM-15-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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