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

  • Czech Republic
      • Praha, Czech Republic, 15030
        • Nemocnice Na Homolce
  • Germany
    • Franken
      • Würzburg, Franken, Germany, 97080
        • Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I
  • Slovakia
      • Bratislava, Slovakia, 83348
        • NUSCH

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
every 4 hours up to 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Accuracy of Respiratory rate determined by impedance measurements
Time Frame: every 4 hours up to 48 hours
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
every 4 hours up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

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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