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Blind Assessment of the Concordance Between the Administered Treatment and the Recommendations of a Medical Algorithm Decision Support Software in Systolic Heart Failure (PREMEDIC)

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ClinicalTrials.gov Identifier: NCT02900547
Recruitment Status : Unknown
Verified June 2016 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

The PREMEDIC is a prospective, observational study. Patients hospitalized for Systolic Heart Failure will be enrolled and health data will be collected at hospital admission and during hospital stay. No data will be collected before detailed information is given to the patient and a non-opposition is obtained.

The aim of this observational and prospective study is to evaluate the concordance actual patient management during the in hospital treatment of heart failure and the therapeutic proposals from a medical algorithmic decision support software.


Condition or disease Intervention/treatment
Hearth Failure, Systolic Other: Patients with systolic heart failure

Detailed Description:

Main Objective:

The aim of this observational and prospective study is to evaluate retrospectively the concordance between the actual systolic heart failure patient management during the inhospital treatment of heart failure (as recorded from the usual healthcare data collected) and the therapeutic proposals from a medical algorithmic decision support software.

Secondary Objectives:

To study the evolution of biological, hepatic and cardiopulmonary ultrasound usual markers in hospitalization, in connection with the duration of hospitalization and drug administered.


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Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Blind Assessment of the Concordance Between the Administered Treatment and the Recommendations of a Medical Algorithm Decision Support Software in Systolic Heart Failure
Study Start Date : July 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. Retrospective evaluation of the concordance between the drug therapy actually used and the therapeutic algorithm's proposals [ Time Frame: an average of 7 days ]

Secondary Outcome Measures :
  1. Duration of hospitalization (number of days) [ Time Frame: an average of 7 days ]
  2. Weight evolution (Kilograms) [ Time Frame: an average of 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized for acutely decompensated systolic heart failure
Criteria

Inclusion Criteria:

  • 18 years old or over
  • Patients hospitalized for decompensated systolic heart failure
  • Patients informed

Exclusion Criteria:

  • Patients unwillingness to participate

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): NCT02900547


Contacts
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Contact: Patrick ROSSIGNOL, Professor 0033383157322 ext +33 p.rossignol@chru-nancy.fr
Contact: Nicolas GIRERD 0033383157322 ext +33 n.girerd@chru-nancy.fr

Locations
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France
CHRU de Nancy Recruiting
Nancy, France
Contact: Patrick Rossignol, Prof         
Principal Investigator: Patrick Rossignol, Prof         
Sub-Investigator: Nicolas GIRERD         
Sponsors and Collaborators
Central Hospital, Nancy, France

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02900547     History of Changes
Other Study ID Numbers: R2015-15
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: June 2016
Keywords provided by Central Hospital, Nancy, France:
Systolic Heart Failure
medical algorithm decision support system
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases