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Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT01509495
Date of registration:	07/12/2011
Prospective Registration:	No
Primary sponsor:	Medtronic BRC
Public title:	Impedance Measurements in Heart Failure Patients SIM-HF
Scientific title:	Impedance Measurements in Heart Failure Patients
Date of first enrolment:	December 2011
Target sample size:	20
Recruitment status:	Terminated
URL:	http://clinicaltrials.gov/show/NCT01509495
Study type:	Interventional
Study design:	Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Phase:	Phase 1

Countries of recruitment
Czech Republic	Germany	Slovakia

Contacts

Name:	Eva Goncalvesova, Prof.
Address:
Telephone:
Email:
Affiliation:	NUSCH, Cardiac Surgery, Pod Krasnou horkou 1, 83348 Bratislava, Slovakia

Name:	Sebastian KG Maier, Prof.
Address:
Telephone:
Email:
Affiliation:	Klinikum St. Elisabeth Straubing, Med. Klinik II, St.-Elisabeth-Str. 23, 94315 Straubing, Germany

Name:	Petr Neuzil, Prof.
Address:
Telephone:
Email:
Affiliation:	Nemocnice Na Homolce, Cardiology, Roentgenova 2/37, 150 30 Praha 5, Czechia

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Device: Akern BIA101 and Custom Device

Primary Outcome(s)

Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement [Time Frame: every 4 hours up to 48 hours]

Secondary Outcome(s)

Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional) [Time Frame: every 4 hours up to 48 hours]

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

Secondary ID(s)

RAE00564

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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