- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01509495
Impedance Measurements in Heart Failure Patients (SIM-HF)
July 3, 2014 updated by: Medtronic BRC
The purpose of this study is to measure impedance during inpatient treatment.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Praha, Czech Republic, 15030
- Nemocnice Na Homolce
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Franken
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Würzburg, Franken, Germany, 97080
- Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I
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Bratislava, Slovakia, 83348
- NUSCH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients admitted to hospital for symptoms of congestive heart failure
- patients older than 18 years
- patients willing and able to give informed consent
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement
Time Frame: every 4 hours up to 48 hours
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every 4 hours up to 48 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Accuracy of Respiratory rate determined by impedance measurements
Time Frame: every 4 hours up to 48 hours
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every 4 hours up to 48 hours
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Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional)
Time Frame: every 4 hours up to 48 hours
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every 4 hours up to 48 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sebastian KG Maier, Prof., Klinikum St. Elisabeth Straubing, Med. Klinik II, St.-Elisabeth-Str. 23, 94315 Straubing, Germany
- Principal Investigator: Eva Goncalvesova, Prof., NUSCH, Cardiac Surgery, Pod Krasnou horkou 1, 83348 Bratislava, Slovakia
- Principal Investigator: Petr Neuzil, Prof., Nemocnice Na Homolce, Cardiology, Roentgenova 2/37, 150 30 Praha 5, Czechia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
December 7, 2011
First Submitted That Met QC Criteria
January 10, 2012
First Posted (Estimate)
January 13, 2012
Study Record Updates
Last Update Posted (Estimate)
July 4, 2014
Last Update Submitted That Met QC Criteria
July 3, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAE00564
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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