Heart FailurePhase 1SIM-HFNCT01509495
Impedance Measurements in Heart Failure Patients
A Phase 1 study testing Akern BIA101 and Custom Device in people with Heart Failure, run by Medtronic BRC at 3 sites in 3 countries.
Trial summary
The purpose of this study is to measure impedance during inpatient treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Akern BIA101 and Custom Device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Dec 2011to May 2014
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients admitted to hospital for symptoms of congestive heart failure
- patients older than 18 years
- patients willing and able to give informed consent
Who cannot join
- patients who will require adrenergic or positive inotropic medications
- patients enrolled in a concurrent study that may confound the results of this study
- patients unable or unwilling to participate in study procedures
- patients who are pregnant
- patients who are mentally handicapped or legal incompetent
- patients who are dependent on investigator or sponsor
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I
Würzburg, Franken, 97080
About this study
The purpose of this study is to measure impedance during inpatient treatment.
- Conditions
- Heart Failure
- Being tested
- Akern BIA101 and Custom Device
- Keywords
- Heart Failure, HF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akern BIA101 and Custom DeviceDevice
Impedance Measurement every 4 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement
Measured: every 4 hours up to 48 hours
Secondary outcomes (2)
Accuracy of Respiratory rate determined by impedance measurements
Measured: every 4 hours up to 48 hours
Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional)
Measured: every 4 hours up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Enrollment rate too low; rate much under estimation of sponsor and investigators
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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastian KG Maier, Prof., Principal investigator, Klinikum St. Elisabeth Straubing, Med. Klinik II, St.-Elisabeth-Str. 23, 94315 Straubing, GermanyEva Goncalvesova, Prof., Principal investigator, NUSCH, Cardiac Surgery, Pod Krasnou horkou 1, 83348 Bratislava, SlovakiaPetr Neuzil, Prof., Principal investigator, Nemocnice Na Homolce, Cardiology, Roentgenova 2/37, 150 30 Praha 5, Czechia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509495
- Sponsor's protocol ID
- RAE00564
- Acronym
- SIM-HF
- Status last verified
- May 2014
- First submitted
- 7 Dec 2011
- Last updated
- 4 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impedance Measurements in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01509495
- Acronym / sponsor ID
- SIM-HF / RAE00564
- Conditions
- Heart Failure
- Keywords
- Heart Failure, HF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment rate too low; rate much under estimation of sponsor and investigators
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Jan 2012 (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 purpose of this study is to measure impedance during inpatient treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients admitted to hospital for symptoms of congestive heart failure
- patients older than 18 years
- patients willing and able to give informed consent
Key exclusion criteria (6 listed)
- patients who will require adrenergic or positive inotropic medications
- patients enrolled in a concurrent study that may confound the results of this study
- patients unable or unwilling to participate in study procedures
- patients who are pregnant
- patients who are mentally handicapped or legal incompetent
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 |
|---|---|---|
| Akern BIA101 and Custom DeviceImpedance Measurement every 4 hours | Device | – |
Primary outcome
Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement
Time frame: every 4 hours up to 48 hours
2 secondary outcomes
Accuracy of Respiratory rate determined by impedance measurements
Time frame: every 4 hours up to 48 hours
Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional)
Time frame: every 4 hours up to 48 hours
Results and safety
The study was stopped early (reason given: Enrollment rate too low; rate much under estimation of sponsor and investigators). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
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Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
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Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
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RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
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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.
Sebastian KG Maier, Prof. principal investigator
Klinikum St. Elisabeth Straubing, Med. Klinik II, St.-Elisabeth-Str. 23, 94315 Straubing, Germany
Eva Goncalvesova, Prof. principal investigator
NUSCH, Cardiac Surgery, Pod Krasnou horkou 1, 83348 Bratislava, Slovakia
Petr Neuzil, Prof. principal investigator
Nemocnice Na Homolce, Cardiology, Roentgenova 2/37, 150 30 Praha 5, Czechia
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Akern BIA101 and Custom Device in people with Heart Failure, run by Medtronic BRC at 3 sites in 3 countries.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 4 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Germany, Slovakia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment rate too low; rate much under estimation of sponsor and investigators). 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?
Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement (time frame: every 4 hours up to 48 hours). 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 4 Jul 2014.