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Impedance Measurements in Heart Failure Patients (SIM-HF)

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Akern BIA101 and Custom Device
Sponsored by
Medtronic BRC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Heart Failure, HF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nemocnice Na Homolce
  • Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I
  • NUSCH

Outcomes

Primary Outcome Measures

Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement

Secondary Outcome Measures

Accuracy of Respiratory rate determined by impedance measurements
Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional)

Full Information

First Posted
December 7, 2011
Last Updated
July 3, 2014
Sponsor
Medtronic BRC
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1. Study Identification

Unique Protocol Identification Number
NCT01509495
Brief Title
Impedance Measurements in Heart Failure Patients
Acronym
SIM-HF
Official Title
Impedance Measurements in Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Enrollment rate too low; rate much under estimation of sponsor and investigators
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic BRC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, HF

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Akern BIA101 and Custom Device
Intervention Description
Impedance Measurement every 4 hours
Primary Outcome Measure Information:
Title
Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement
Time Frame
every 4 hours up to 48 hours
Secondary Outcome Measure Information:
Title
Accuracy of Respiratory rate determined by impedance measurements
Time Frame
every 4 hours up to 48 hours
Title
Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional)
Time Frame
every 4 hours up to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian KG Maier, Prof.
Organizational Affiliation
Klinikum St. Elisabeth Straubing, Med. Klinik II, St.-Elisabeth-Str. 23, 94315 Straubing, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eva Goncalvesova, Prof.
Organizational Affiliation
NUSCH, Cardiac Surgery, Pod Krasnou horkou 1, 83348 Bratislava, Slovakia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petr Neuzil, Prof.
Organizational Affiliation
Nemocnice Na Homolce, Cardiology, Roentgenova 2/37, 150 30 Praha 5, Czechia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemocnice Na Homolce
City
Praha
ZIP/Postal Code
15030
Country
Czech Republic
Facility Name
Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I
City
Würzburg
State/Province
Franken
ZIP/Postal Code
97080
Country
Germany
Facility Name
NUSCH
City
Bratislava
ZIP/Postal Code
83348
Country
Slovakia

12. IPD Sharing Statement

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Impedance Measurements in Heart Failure Patients

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