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Clinical Trials/NCT02662439
NCT02662439
Suspended
Not Applicable

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

Peter Studinger1 site in 1 country240 target enrollmentFebruary 2016
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ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Peter Studinger
Enrollment
240
Locations
1
Primary Endpoint
Re-hospitalization rate
Status
Suspended
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
December 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Peter Studinger
Responsible Party
Sponsor Investigator
Principal Investigator

Peter Studinger

Assistant Professor

Semmelweis University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Re-hospitalization rate

Time Frame: 12 months

Secondary Outcomes

  • All cause mortality(12 months)

Study Sites (1)

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