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Not Invasive Monitoring at Cardiac Recompensation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01775306
First Posted: January 24, 2013
Last Update Posted: January 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
RWTH Aachen University
  Purpose
The aim of this study is to find out if data can be provided by external sensor technology which is suitable for controlling the therapy of patients with cardiac recompensation.

Condition
Cardiac Recompensation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • suitable Data [ Time Frame: 15 minutes per day and per patient, 3-5 days, at most 14 days ]

Enrollment: 49
Study Start Date: October 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cardiac recompensation
Criteria

Inclusion Criteria:

  • patients with acute or chronic cardiac decompensation with and without pulmonary oedema
  • male and female patients aged at least 18 years

Exclusion Criteria:

  • pregnancy or breast feeding
  • implanted pacemaker / CRT / ICD exept Medtronic OptiVol
  • patients being unable to consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775306


Locations
Germany
Univeristy Hospital Aachen
Aachen, North Rhine Westfalia, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
  More Information

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01775306     History of Changes
Other Study ID Numbers: 10-081
First Submitted: January 22, 2013
First Posted: January 24, 2013
Last Update Posted: January 8, 2014
Last Verified: January 2014