NCT01509495

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 heart-failure

Timeline
Completed

Started Dec 2011

Typical duration for phase_1 heart-failure

Geographic Reach
3 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 4, 2014

Status Verified

May 1, 2014

Enrollment Period

2.4 years

First QC Date

December 7, 2011

Last Update Submit

July 3, 2014

Conditions

Heart Failure

Keywords

Heart FailureHF

Outcome Measures

Primary Outcomes (1)

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

    every 4 hours up to 48 hours

Secondary Outcomes (2)

  • Accuracy of Respiratory rate determined by impedance measurements

    every 4 hours up to 48 hours

  • Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional)

    every 4 hours up to 48 hours

Interventions

Akern BIA101 and Custom DeviceDEVICE

Impedance Measurement every 4 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients admitted to hospital for symptoms of congestive heart failure
  • patients older than 18 years
  • patients willing and able to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nemocnice Na Homolce

Prague, 15030, Czechia

Location

Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I

Würzburg, Franken, 97080, Germany

Location

NUSCH

Bratislava, 83348, Slovakia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2011

First Posted

January 13, 2012

Study Start

December 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 4, 2014

Record last verified: 2014-05

Locations

DE(1)SL(1)CZ(1)