Not Invasive Monitoring at Cardiac Recompensation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01775306
First received: January 22, 2013
Last updated: January 7, 2014
Last verified: January 2014
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775306

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

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01775306     History of Changes
Other Study ID Numbers: 10-081
Study First Received: January 22, 2013
Last Updated: January 7, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on August 20, 2014