Heart DecompensationRACING-HFNCT04703504
RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization
A study testing Multiple intervention program in people with Heart Decompensation, run by French Cardiology Society at 8 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Decompensation
- What is being tested?
- Multiple intervention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 8 sitesFrance
- Study dates
- 15 Jul 2022to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart decompensation requiring hospitalization and the use of intravenous diuretic therapy
- Left Ventricular Ejection Fraction ≤ 40%.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Hôpital Paul d'Egine
Champigny-sur-Marne
Hôpital Henri Mondor
Créteil
Hôpital Simone Veil
Eaubonne
Hôpitaux Nord-Ouest de Villefranche
Gleizé, 69655
Hôpital Européen Georges Pompidou
Paris
Polyclinique de Poitiers
Poitiers, 86000
Centre Cardiologique du Nord
Saint-Denis
Centre Hopsitalier Lucie et Raymond Aubrac
Villeneuve-Saint-Georges
About this study
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.
Read the 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.
- Conditions
- Heart Decompensation
- Being tested
- Multiple intervention program
- Keywords
- heart failure, multiple intervention program
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple intervention programOther
Support for patient follow-up assisted by a computer program
| Study group | Role | What they receive |
|---|---|---|
| multi-intervention | Experimental | * 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 Receives: Other: Multiple intervention program |
| Control | No intervention | Discharge prescription according to the investigator's habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (6)
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.
Measured: 12 months
Number of re-hospitalization due to heart decompensation per patient
Defined as total number of hospitalization for heart decompensation during 1 year
Measured: 12 months
Delay between discharge and re-hospitalization due to heart decompensation
Defined as time to first occurrence of re-hospitalization due to heart decompensation
Measured: 12 months
Number of participants with death
Measured: 3 months
Number of participants with death
Measured: 12 months
Rate of pacemaker implantation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start15 Jul 2022
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Why it stopped: Recruitment targets will not be met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DecompensationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Arnaud GALAT, MD, Principal investigator, CHU Henri Mondor, Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703504
- Sponsor's protocol ID
- 2016-06
- Acronym
- RACING-HF
- Status last verified
- Oct 2024
- First submitted
- 7 Jan 2021
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization
- ClinicalTrials.gov ID
- NCT04703504
- Acronym / sponsor ID
- RACING-HF / 2016-06
- Conditions
- Heart Decompensation
- Keywords
- heart failure, multiple intervention program
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment targets will not be met
- Enrolment
- 25 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multi-intervention | Experimental | Other: Multiple intervention program* 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 |
| Control | No intervention | –Discharge prescription according to the investigator's habits. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heart decompensation requiring hospitalization and the use of intravenous diuretic therapy
- Left Ventricular Ejection Fraction ≤ 40%.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple intervention programSupport for patient follow-up assisted by a computer program | Other | multi-intervention |
Primary outcome
Number of participants with a re-hospitalization due to heart decompensation
Time frame: 3 months
Defined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.
6 secondary outcomes
Number of participants with a re-hospitalization due to heart decompensation
Time frame: 12 months
Number of re-hospitalization due to heart decompensation per patient
Time frame: 12 months
Delay between discharge and re-hospitalization due to heart decompensation
Time frame: 12 months
Number of participants with death
Time frame: 3 months
Number of participants with death
Time frame: 12 months
Rate of pacemaker implantation
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Recruitment targets will not be met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Association Between the Sit-To-Stand Test and the Prognosis of Patients With Heart Failure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud GALAT, MD principal investigator
CHU Henri Mondor, Créteil
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple intervention program in people with Heart Decompensation, run by French Cardiology Society at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment targets will not be met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a re-hospitalization due to heart decompensation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024; AzTrials last refreshed its copy on 28 Oct 2026.