Back to resultsBioimpedance Analysis in Chronic Heart Failure
Primary Purpose
Heart Failure
Status
Suspended
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Body Composition Monitor (BCM)
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring Heart Failure, Bioimpedance analysis, Fluid overload
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
Sites / Locations
- First Department of Medicine, Semmelweis University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BCM group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Re-hospitalization rate
Secondary Outcome Measures
All cause mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02662439
Brief Title
Bioimpedance Analysis in Chronic Heart Failure
Official Title
Role of the Bioimpedance Analysis in Guiding the Diuretic Therapy in Chronic Heart Failure - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Suspended
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Studinger
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Bioimpedance analysis, Fluid overload
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BCM group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Body Composition Monitor (BCM)
Intervention Description
In the experimental group, the diuretic therapy adjusted according to the result of the BCM analysis.
Primary Outcome Measure Information:
Title
Re-hospitalization rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
Measured by validated questionnaire
Time Frame
3 months
Title
Renal function decline
Description
Measured by estimated glomerular filtration rate (ml/min/1.73m2)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Studinger, MD, PhD
Organizational Affiliation
First Department of Medicine, Semmelweis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Department of Medicine, Semmelweis University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
Bioimpedance Analysis in Chronic Heart Failure
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