Clinical trial NCT04703504: RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization
Official title: RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Decompensation
Keywords: heart failure
multiple intervention program
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2021-01-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of participants with a re-hospitalization due to heart decompensation
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants with a re-hospitalization due to heart decompensation
timeFrame: 12 months
measure: Number of re-hospitalization due to heart decompensation per patient
timeFrame: 12 months
measure: Delay between discharge and re-hospitalization due to heart decompensation
timeFrame: 12 months
measure: Number of participants with death
timeFrame: 3 months
measure: Number of participants with death
timeFrame: 12 months
measure: Rate of pacemaker implantation
timeFrame: 12 months
Other outcomes:
Locations:
city: Champigny-sur-Marne
country: France
facility: Hôpital Paul d'Egine
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Eaubonne
country: France
facility: Hôpital Simone Veil
city: Gleizé
country: France
facility: Hôpitaux Nord-Ouest de Villefranche
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Poitiers
country: France
facility: Polyclinique de Poitiers
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Villeneuve-Saint-Georges
country: France
facility: Centre Hopsitalier Lucie et Raymond Aubrac
Study officials:
affiliation: CHU Henri Mondor, Créteil
name: Arnaud GALAT, MD
role: PRINCIPAL_INVESTIGATOR
References: