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RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization (RACING-HF)

Primary Purpose

Heart Decompensation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multiple intervention program
Sponsored by
French Cardiology Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Decompensation focused on measuring heart failure, multiple intervention program

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Heart decompensation requiring hospitalization and the use of intravenous diuretic therapy
  • Left Ventricular Ejection Fraction ≤ 40%.

Exclusion Criteria:

  • Hospitalization for cardiac decompensation leading to an invasive procedure (valve, coronary, etc.).
  • Acute reversible cause of heart failure.
  • Incurable disease (other than heart failure) or estimated life expectancy of less than one year.
  • Patient transferred directly to another department or cardiac rehabilitation center.
  • Significant cognitive impairment.
  • Patient without cell phone or email.
  • Linguistic or psychic refusal or inability to sign the informed consent.
  • Current participation in a clinical tria

Sites / Locations

  • Hôpital Paul d'EgineRecruiting
  • Hôpital Henri MondorRecruiting
  • Hôpital Simone Veil
  • Hôpitaux Nord-Ouest de Villefranche
  • Hôpital Européen Georges Pompidou
  • Polyclinique de Poitiers
  • Centre Cardiologique du Nord
  • Centre Hopsitalier Lucie et Raymond Aubrac

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

multi-intervention

Control

Arm Description

Automatic creation of discharge prescription (personalized checklist of possible therapeutic optimizations generated from clinical data entered into the platform. This checklist will comply with the recommendations on altered left ventricular ejection fraction from European Society of Cardiology 2016. Automatic creation of documents for patient: Reminder letter to make an appointment with his general practitioner (at 7 days) and cardiologist (1 month) and to report the prescribed blood test. Drug prescription. Prescription for blood tests (5 days and 25 days before seeing the general practitioner and cardiologist). Therapeutic education documents Patients will receive numerous messages (SMS / e-mail) in order to 1 / not forget their medical appointments, 2 / not to forget to make and bring back their blood test for the consultation, 3 / to perfect the therapeutic education advice provided previously

Discharge prescription according to the investigator's habits.

Outcomes

Primary Outcome Measures

Number of participants with a re-hospitalization due to heart decompensation
Defined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.

Secondary Outcome Measures

Number of participants with a re-hospitalization due to heart decompensation
Defined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.
Number of re-hospitalization due to heart decompensation per patient
Defined as total number of hospitalization for heart decompensation during 1 year
Delay between discharge and re-hospitalization due to heart decompensation
Defined as time to first occurrence of re-hospitalization due to heart decompensation
Number of participants with death
Number of participants with death
Rate of pacemaker implantation

Full Information

First Posted
January 7, 2021
Last Updated
June 16, 2023
Sponsor
French Cardiology Society
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04703504
Brief Title
RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization
Acronym
RACING-HF
Official Title
RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
Collaborators
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The prevalence of heart failure (HF) is constantly increasing in France due to the aging of the population, better management of etiological factors and improved treatments (drug / interventional). On the other hand, re-hospitalizations for heart failure continue to increase, exceeding reception capacities and constitute a real challenge for current public health systems. The PRADO system provides administrative support (through a health insurance advisor) in the management of patient appointments with their doctors as well as home visits by a nurse trained in heart failure. Other interventional medical and educational interventions performed during an out-of-hospital consultation guided by a computer platform would help to optimize the care and continuity of care.
Detailed Description
The aim of this study is to demonstrate the value of a multiple intervention program in reducing early readmissions for heat failure in patients hospitalized for cardiac decompensation. This work will create an interventional assistance program to structure the exit consultation in order to optimize treatment, educate patients, ensure the continuity of hospital-city care and improve compliance (reminders) to reduce re-hospitalizations. This program will be carried out by using a computer platform allowing the systematization of output documents and the sending of messages (e-mail / SMS) for making appointments (medical consultations, biologicals sampling) and perfect therapeutic education.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Decompensation
Keywords
heart failure, multiple intervention program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
multi-intervention
Arm Type
Experimental
Arm Description
Automatic creation of discharge prescription (personalized checklist of possible therapeutic optimizations generated from clinical data entered into the platform. This checklist will comply with the recommendations on altered left ventricular ejection fraction from European Society of Cardiology 2016. Automatic creation of documents for patient: Reminder letter to make an appointment with his general practitioner (at 7 days) and cardiologist (1 month) and to report the prescribed blood test. Drug prescription. Prescription for blood tests (5 days and 25 days before seeing the general practitioner and cardiologist). Therapeutic education documents Patients will receive numerous messages (SMS / e-mail) in order to 1 / not forget their medical appointments, 2 / not to forget to make and bring back their blood test for the consultation, 3 / to perfect the therapeutic education advice provided previously
Arm Title
Control
Arm Type
No Intervention
Arm Description
Discharge prescription according to the investigator's habits.
Intervention Type
Other
Intervention Name(s)
Multiple intervention program
Intervention Description
Support for patient follow-up assisted by a computer program
Primary Outcome Measure Information:
Title
Number of participants with a re-hospitalization due to heart decompensation
Description
Defined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of participants with a re-hospitalization due to heart decompensation
Description
Defined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.
Time Frame
12 months
Title
Number of re-hospitalization due to heart decompensation per patient
Description
Defined as total number of hospitalization for heart decompensation during 1 year
Time Frame
12 months
Title
Delay between discharge and re-hospitalization due to heart decompensation
Description
Defined as time to first occurrence of re-hospitalization due to heart decompensation
Time Frame
12 months
Title
Number of participants with death
Time Frame
3 months
Title
Number of participants with death
Time Frame
12 months
Title
Rate of pacemaker implantation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heart decompensation requiring hospitalization and the use of intravenous diuretic therapy Left Ventricular Ejection Fraction ≤ 40%. Exclusion Criteria: Hospitalization for cardiac decompensation leading to an invasive procedure (valve, coronary, etc.). Acute reversible cause of heart failure. Incurable disease (other than heart failure) or estimated life expectancy of less than one year. Patient transferred directly to another department or cardiac rehabilitation center. Significant cognitive impairment. Patient without cell phone or email. Linguistic or psychic refusal or inability to sign the informed consent. Current participation in a clinical tria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud GALAT, MD
Phone
+33 1 49 81 22 53
Email
arnault.galat@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Tessa BERGOT
Phone
+33 1 44 90 70 33
Email
tessa.bergot@sfcardio.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud GALAT, MD
Organizational Affiliation
CHU Henri Mondor, Créteil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Paul d'Egine
City
Champigny-sur-Marne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane COSSON, MD
Facility Name
Hôpital Henri Mondor
City
Créteil
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud GALAT, MD
Facility Name
Hôpital Simone Veil
City
Eaubonne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nachwan GHANEM, MD
Facility Name
Hôpitaux Nord-Ouest de Villefranche
City
Gleizé
ZIP/Postal Code
69655
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier LEVAVASSEUR, MD
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert HAGEGE, MD
Facility Name
Polyclinique de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barnabas GELLEN, MD
Facility Name
Centre Cardiologique du Nord
City
Saint-Denis
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David ATTIAS, MD
Facility Name
Centre Hopsitalier Lucie et Raymond Aubrac
City
Villeneuve-Saint-Georges
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel SALENGRO, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization

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