Impedance Measurements in Heart Failure Patients

NCT ID: NCT01509495

Last Updated: 2014-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Akern BIA101 and Custom Device

Impedance Measurement every 4 hours

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic BRC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastian KG Maier, Prof.

Role: PRINCIPAL_INVESTIGATOR

Klinikum St. Elisabeth Straubing, Med. Klinik II, St.-Elisabeth-Str. 23, 94315 Straubing, Germany

Eva Goncalvesova, Prof.

Role: PRINCIPAL_INVESTIGATOR

NUSCH, Cardiac Surgery, Pod Krasnou horkou 1, 83348 Bratislava, Slovakia

Petr Neuzil, Prof.

Role: PRINCIPAL_INVESTIGATOR

Nemocnice Na Homolce, Cardiology, Roentgenova 2/37, 150 30 Praha 5, Czechia

Locations

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Nemocnice Na Homolce

Prague, , Czechia

Site Status

Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I

Würzburg, Franken, Germany

Site Status

NUSCH

Bratislava, , Slovakia

Site Status

Countries

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Czechia Germany Slovakia

Other Identifiers

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RAE00564

Identifier Type: -

Identifier Source: org_study_id

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