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

Hearth Failure, Systolic Clinical Trial

— PREMEDIC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02900547
• Other study ID #: R2015-15
• Status: Recruiting
• Phase: N/A
• First received: August 12, 2016
• Last updated: September 9, 2016
• Start date: July 2015
• Est. completion date: June 2018

Study information

• Verified date: June 2016
• Source: Central Hospital, Nancy, France
• Contact: Patrick ROSSIGNOL, Professor
• Phone: 0033383157322
• Email: p.rossignol[@]chru-nancy.fr
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or over

• Patients hospitalized for decompensated systolic heart failure

• Patients informed

Exclusion Criteria:

• Patients unwillingness to participate

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Hearth Failure, Systolic

Intervention

Other:
• Patients with systolic heart failure

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective evaluation of the concordance between the drug therapy actually used and the therapeutic algorithm's proposals		an average of 7 days	No
Secondary	Duration of hospitalization (number of days)		an average of 7 days	No
Secondary	Weight evolution (Kilograms)		an average of 7 days	No