NCT02662439

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
240

participants targeted

Target at P75+ for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

January 14, 2016

Last Update Submit

May 31, 2017

Conditions

Heart Failure

Keywords

Heart FailureBioimpedance analysisFluid overload

Outcome Measures

Primary Outcomes (1)

  • Re-hospitalization rate

    12 months

Secondary Outcomes (1)

  • All cause mortality

    12 months

Other Outcomes (2)

  • Quality of life

    3 months

  • Renal function decline

    3 months

Study Arms (2)

BCM group

EXPERIMENTAL

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)

Control group

PLACEBO COMPARATOR

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)

Interventions

Body Composition Monitor (BCM)DEVICE

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

BCM groupControl group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with known or newly discovered chronic heart failure admitted to hospital because of the clinical signs of acut cardiac decompensation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Department of Medicine, Semmelweis University

Budapest, 1083, Hungary

Location

MeSH Terms

Conditions

Heart FailureEdema

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Studinger, MD, PhD

    First Department of Medicine, Semmelweis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 25, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2018

Last Updated

June 1, 2017

Record last verified: 2017-05

Locations

HU(1)