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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04703504
Acronym
RACING-HF
Enrollment
25
Registered
2021-01-11
Start date
2022-07-15
Completion date
2024-09-20
Last updated
2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Decompensation

Keywords

heart failure, multiple intervention program

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.

Interventions

OTHERMultiple intervention program

Support for patient follow-up assisted by a computer program

Sponsors

Bayer
CollaboratorINDUSTRY
French Cardiology Society
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with a re-hospitalization due to heart decompensation3 monthsDefined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.

Secondary

MeasureTime frameDescription
Number of participants with a re-hospitalization due to heart decompensation12 monthsDefined 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 patient12 monthsDefined as total number of hospitalization for heart decompensation during 1 year
Delay between discharge and re-hospitalization due to heart decompensation12 monthsDefined as time to first occurrence of re-hospitalization due to heart decompensation
Number of participants with death3 months
Rate of pacemaker implantation12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026