Heart FailureNCT02662439
Bioimpedance Analysis in Chronic Heart Failure
A study testing Body Composition Monitor (BCM) in people with Heart Failure, run by Peter Studinger at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Body Composition Monitor (BCM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteHungary
- Study dates
- Feb 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known or newly discovered chronic heart failure admitted to hospital because of the clinical signs of acut cardiac decompensation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hungary1 site
First Department of Medicine, Semmelweis University
Budapest, 1083
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Body Composition Monitor (BCM)
- Keywords
- Heart Failure, Bioimpedance analysis, Fluid overload
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Composition Monitor (BCM)Device
In the experimental group, the diuretic therapy adjusted according to the result of the BCM analysis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Body Composition Monitor (BCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-hospitalization rate
Measured: 12 months
Secondary outcomes (1)
All cause mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Studinger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Studinger, Semmelweis University
- Investigators
- Peter Studinger, MD, PhD, Principal investigator, First Department of Medicine, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662439
- Sponsor's protocol ID
- HF-BCM-15-1
- Status last verified
- May 2017
- First submitted
- 14 Jan 2016
- Last updated
- 1 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Bioimpedance Analysis in Guiding the Diuretic Therapy in Chronic Heart Failure - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02662439
- Acronym / sponsor ID
- HF-BCM-15-1
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Bioimpedance analysis, Fluid overload
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peter StudingerUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2018 (estimated)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCM group | Experimental | Device: Body Composition Monitor (BCM)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. |
| Control group | Placebo comparator | Device: Body Composition Monitor (BCM)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with known or newly discovered chronic heart failure admitted to hospital because of the clinical signs of acut cardiac decompensation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Composition Monitor (BCM)In the experimental group, the diuretic therapy adjusted according to the result of the BCM analysis. | Device | BCM group, Control group |
Primary outcome
Re-hospitalization rate
Time frame: 12 months
1 secondary outcome
All cause mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Studinger, MD, PhD principal investigator
First Department of Medicine, Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Composition Monitor (BCM) in people with Heart Failure, run by Peter Studinger at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-hospitalization rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.