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

Heart Decompensation Clinical Trial

— RACING-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04703504
• Other study ID #: 2016-06
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: April 30, 2026

Study information

• Verified date: June 2023
• Source: French Cardiology Society
• Contact: Arnaud GALAT, MD
• Phone: +33 1 49 81 22 53
• Email: arnault.galat[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Decompensation
• Heart Failure

Intervention

Other:
• Multiple intervention program
Support for patient follow-up assisted by a computer program

Locations

Country	Name	City	State
France	Hôpital Paul d'Egine	Champigny-sur-Marne
France	Hôpital Henri Mondor	Créteil
France	Hôpital Simone Veil	Eaubonne
France	Hôpitaux Nord-Ouest de Villefranche	Gleizé
France	Hôpital Européen Georges Pompidou	Paris
France	Polyclinique de Poitiers	Poitiers
France	Centre Cardiologique du Nord	Saint-Denis
France	Centre Hopsitalier Lucie et Raymond Aubrac	Villeneuve-Saint-Georges

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	12 months
Secondary	Number of re-hospitalization due to heart decompensation per patient	Defined as total number of hospitalization for heart decompensation during 1 year	12 months
Secondary	Delay between discharge and re-hospitalization due to heart decompensation	Defined as time to first occurrence of re-hospitalization due to heart decompensation	12 months
Secondary	Number of participants with death		3 months
Secondary	Number of participants with death		12 months
Secondary	Rate of pacemaker implantation		12 months