Impedance Measurements in Heart Failure Patients (SIM-HF)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT01509495
First received: December 7, 2011
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Heart Failure
Device: Akern BIA101 and Custom Device
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Impedance Measurements in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Medtronic BRC:

Primary Outcome Measures:
  • Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement [ Time Frame: every 4 hours up to 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Accuracy of Respiratory rate determined by impedance measurements [ Time Frame: every 4 hours up to 48 hours ] [ Designated as safety issue: No ]
  • Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional) [ Time Frame: every 4 hours up to 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Akern BIA101 and Custom Device
    Impedance Measurement every 4 hours
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509495

Locations
Czech Republic
Nemocnice Na Homolce
Praha, Czech Republic, 15030
Germany
Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I
Würzburg, Franken, Germany, 97080
Slovakia
NUSCH
Bratislava, Slovakia, 83348
Sponsors and Collaborators
Medtronic BRC
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
  More Information

No publications provided

Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT01509495     History of Changes
Other Study ID Numbers: RAE00564
Study First Received: December 7, 2011
Last Updated: November 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic BRC:
Heart Failure
HF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014