Impedance Measurements in Heart Failure Patients

Heart Failure Clinical Trial

— SIM-HF  

Official title:

Impedance Measurements in Heart Failure Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01509495
• Other study ID #: RAE00564
• Status: Terminated
• Phase: Phase 1
• First received: December 7, 2011
• Last updated: July 3, 2014
• Start date: December 2011
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Akern BIA101 and Custom Device
Impedance Measurement every 4 hours

Locations

Country	Name	City	State
Czech Republic	Nemocnice Na Homolce	Praha
Germany	Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I	Würzburg	Franken
Slovakia	NUSCH	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Countries where clinical trial is conducted

Czech Republic,  Germany,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement		every 4 hours up to 48 hours	No
Secondary	Accuracy of Respiratory rate determined by impedance measurements		every 4 hours up to 48 hours	No
Secondary	Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional)		every 4 hours up to 48 hours	No