FREnch Survey on Heart Failure (FRESH)

September 20, 2022 updated by: French Cardiology Society

Heart failure is the most common heart disease with increasing incidence due to the aging of the population is improving the initial prognosis of various conditions that lead to more or less progressive heart failure.

Heart failure is of great variety of clinical and pathophysiological forms necessitating the creation of quality records to clarify each of these forms.

Many types of cardiomyopathies exist, some of which are infrequent but with specific care.

At the French level, few data exist. In addition, the therapeutic management changes regularly.

New European recommendations (endorsed by the French Society of Cardiology = FSC) were published in May 2012. Many therapeutic approaches are being evaluated. The course of care and how to take non-drug load (network monitoring, rehabilitation ...) have become important issues that have hardly been analyzed by existing records.

This also leads to better define the different forms of this disease, their natural history and methods of management applied in real life. The register of FSC follows the registry of the European Society of Cardiology (ESC)"Heart Failure (HF) Long Term" (CCTIRS No. 11.355bis) with inclusions will be completed in November 2012. This new study aims to generate more accurate data on a number of points and be more representative for a wider selection of patients, the French level.

Study Overview

Status

Completed

Conditions

Detailed Description

The recruitment period will be 24 months, with a day of inclusion for each week, which will be included both patients external consultant for chronic heart failure patients hospitalized in the cardiology department, during this day for acute heart failure.

Monitoring will be carried out 12 months during a consultation normally scheduled for this type of pathology with the cardiologist investigator. Patients included in a decompensation will also follow up to 3 months

Study Type

Observational

Enrollment (Actual)

2719

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

  • France
      • PARIS Cedex 10, France, 75475
        • Hopital Lariboisiere

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients over 18 years with chronic heart failure, and all patients hospitalized for acute heart failure de novo or not. The diagnosis of heart failure is the responsibility of the cardiologist including patient.

Description

Inclusion Criteria:

  • patient with chronic HF OR patient hospitalized foor acute HF de novo or not
  • patient who accept to participate by signing a informed consent

Exclusion Criteria:

  • patient who deny to participate

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

Cohorts and Interventions

Group / Cohort
Heart Failure
All patients over 18 years with chronic heart failure, and all patients hospitalized for acute heart failure de novo or not. The diagnosis of heart failure is the responsibility of the cardiologist including patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at one-year of follow-up
Time Frame: 12 months
Death rate at 12 months of follow-up
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity at one year of follow-up
Time Frame: 12 months
Collect Chronic obstructive pulmonary disease (COPD) and diabetes mellitus during one year of follow-up, which frequently are associated with heart failure and impact patient outcomes
12 months

Collaborators and Investigators

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

Sponsor

French Cardiology Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 1, 2014

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 680

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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