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Not Invasive Monitoring at Cardiac Recompensation

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. Identifier: NCT01775306
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : January 8, 2014
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
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 or disease
Cardiac Recompensation

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT01775306

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Univeristy Hospital Aachen
Aachen, North Rhine Westfalia, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
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Responsible Party: RWTH Aachen University Identifier: NCT01775306    
Other Study ID Numbers: 10-081
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014