Impedance Measurements in Heart Failure Patients (SIM-HF)

This study has been terminated.
(Enrollment rate too low; rate much under estimation of sponsor and investigators)
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT01509495
First received: December 7, 2011
Last updated: July 3, 2014
Last verified: May 2014
  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
Study Completion Date: May 2014
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 3, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic BRC:
Heart Failure
HF

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014