Hearth Failure, SystolicPREMEDICNCT02900547
Blind Assessment of the Concordance Between the Administered Treatment and the Recommendations of a Medical Algorithm Decision Support Software in Systolic Heart Failure
An observational study of Hearth Failure, Systolic, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearth Failure, Systolic
- What is being tested?
- Patients with systolic heart failure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for acutely decompensated systolic heart failure
Who may be able to join
- 18 years old or over
- Patients hospitalized for decompensated systolic heart failure
- Patients informed
Who cannot join
- Patients unwillingness to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Nancy
Patrick Rossignol, Prof
Patrick Rossignol, Prof
About this study
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.
Read the 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.
- Conditions
- Hearth Failure, Systolic
- Being tested
- Patients with systolic heart failure
- Keywords
- Systolic Heart Failure, medical algorithm decision support system
- Medical subject headings
- Systolic Murmurs, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with systolic heart failureOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective evaluation of the concordance between the drug therapy actually used and the therapeutic algorithm's proposals
Measured: an average of 7 days
Secondary outcomes (2)
Duration of hospitalization (number of days)
Measured: an average of 7 days
Weight evolution (Kilograms)
Measured: an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearth Failure, SystolicStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900547
- Sponsor's protocol ID
- R2015-15
- Acronym
- PREMEDIC
- Status last verified
- Jun 2016
- First submitted
- 12 Aug 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02900547
- Acronym / sponsor ID
- PREMEDIC / R2015-15
- Conditions
- Hearth Failure, Systolic
- Keywords
- Systolic Heart Failure, medical algorithm decision support system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for acutely decompensated systolic heart failure
Key inclusion criteria (3 listed)
- 18 years old or over
- Patients hospitalized for decompensated systolic heart failure
- Patients informed
Key exclusion criteria (1 listed)
- Patients unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with systolic heart failure | Other | – |
Primary outcome
Retrospective evaluation of the concordance between the drug therapy actually used and the therapeutic algorithm's proposals
Time frame: an average of 7 days
2 secondary outcomes
Duration of hospitalization (number of days)
Time frame: an average of 7 days
Weight evolution (Kilograms)
Time frame: an average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearth Failure, Systolic, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick ROSSIGNOL, Professor (0033383157322 ext. +33, p.rossignol@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective evaluation of the concordance between the drug therapy actually used and the therapeutic algorithm's proposals (time frame: an average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.