Not Invasive Monitoring at Cardiac Recompensation

January 7, 2014 updated by: RWTH Aachen University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine Westfalia
      • Aachen, North Rhine Westfalia, Germany, 52074
        • Univeristy Hospital Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cardiac recompensation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
suitable Data
Time Frame: 15 minutes per day and per patient, 3-5 days, at most 14 days
15 minutes per day and per patient, 3-5 days, at most 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

January 8, 2014

Last Update Submitted That Met QC Criteria

January 7, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 10-081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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