Impedance Measurements in Heart Failure Patients

NCT01509495 — Phase 1, Terminated, 20 participants, Medtronic BRC

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Registry	NCT01509495, acronym SIM-HF
Status	Terminated - Enrollment rate too low; rate much under estimation of sponsor and investigators
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	20 (Estimated)
Sponsor	Medtronic BRC (Industry)
Conditions	Heart Failure
Interventions	Akern BIA101 and Custom Device (Device)
Dates	start 2011-12-01, primary completion 2014-05-01, completion 2014-05-01, first posted 2012-01-13, last updated 2014-07-04
Locations	3 sites in Czechia, Germany, Slovakia

-Summary

The purpose of this study is to measure impedance during inpatient treatment.

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+Arms and interventions

Akern BIA101 and Custom Device (Device): Impedance Measurement every 4 hours

+Outcome measures

Primary outcomes

Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement [every 4 hours up to 48 hours]

Secondary outcomes

Accuracy of Respiratory rate determined by impedance measurements [every 4 hours up to 48 hours]
Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional) [every 4 hours up to 48 hours]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (3)

Facility	City	Country
Nemocnice Na Homolce	Prague	Czechia
Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I	Würzburg, Franken	Germany
NUSCH	Bratislava	Slovakia

+Investigators

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