Heart FailurePRADO-ICNCT03396081
Efficacy of PRADO Heart Failure in Occitania
A study testing PRADO-IC in people with Heart Failure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Patients with heart failure (IC), after hospitalization, have a marked fragility: in France, in the first year, 29% die and 45% are readmitted to IC. Interventions improving the coordination of care providers at the time of discharge from hospitalization were tested; they showed a reduction in readmissions for IC… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- PRADO-IC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2018to 9 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Hospitalization for heart failure
- Subject living at home
- Informed consent
Who cannot join
- discharge to a rehabilitation clinic or to medical home for elderly people
- subject without health insurance
- terminal kidney failure
- programmed heart surgery
- waiting for heart transplantation
- psycho-cognitive impairment
Show all 12Show fewer
- patient not autonomous for mobility at home
- supportive care
- planned move to medical home for elderly people in the coming 6 months
- no fluent french
- not able to provide informed consent
- participating to other study
Trial locations and contacts
1 site in 1 country.
About this study
Patients with heart failure (IC), after hospitalization, have a marked fragility: in France, in the first year, 29% die and 45% are readmitted to IC. Interventions improving the coordination of care providers at the time of discharge from hospitalization were tested; they showed a reduction in readmissions for IC (relative risk (RR) from 0.51 to 0.74) and all-cause mortality (RR 0.75 to 0.87). The Patient Return Program IC (PRADO IC), set up by the Health Insurance, offers assistance in the initiation of outpatient medical monitoring, and a nursing follow-up of 2 to 6 months depending on the patient's severity. The trial of PRADO began in the second half of 2013, and the first evaluation showed that the time to first treatment was significantly shorter, and that the readmissions rate and the 6-month death rate were unchanged.
This study was of epidemiological type, comparative before-elsewhere. The difficulty of controlling for confounders in this type of study limits the scope of these conclusions. The efficacy hypothesis of PRADO IC is therefore always posed in the French context
- Conditions
- Heart Failure
- Being tested
- PRADO-IC, No intervervention Usual Care
- Keywords
- Heart Failure, Care pathway, Transition program, Efficiency
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRADO-ICBehavioural
- Help of administrative employees to schedule the first medical visits after an hospitalization for heart failure.
- Home nurse's visiting program, during 2 to 6 months after the hospitalization for heart failure.
No intervervention Usual CareBehavioural
Advices about the care pathway, provided by care givers. Prescription of home nurse's visits if needed.
| Study group | Role | What they receive |
|---|---|---|
| PRADO-IC | Experimental | Not described Receives: Behavioral: PRADO-IC |
| Usual care | Other | Not described Receives: Behavioral: No intervervention Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-efficacy ratio
Cost to avoid an hospitalization for heart failure
Measured: 12 months
Secondary outcomes (6)
Cost-utility ratio
Cost will be performed from the society perspective. Utility will be derived from the French EQ5D, measured at 0, 6 and 12 months
Measured: 12 months
Number of hospitalization for heart failure
Hospitalizations for heart failure will be defined using claim data.
Measured: 12 months
Number of all causes hospitalization
Measured: 12 months
Rate of death from cardiovascular disease
Measured: 12 months
Number of general practitionner
Claim data
Measured: 12 months
Number of cardiologist visits
Claim data
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 posted10 Jan 2018
- Study start4 May 2018
- Primary completion9 May 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396081
- Sponsor's protocol ID
- RECHMPL17_0113
- Other IDs
- 2017-A01732-51
- Acronym
- PRADO-IC
- Status last verified
- May 2022
- First submitted
- 26 Dec 2017
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roubille F, Labarre JP, Georger F, Galinier M, Herman F, Berdague P, Nogue E, Petroni T, Delbaere Q, Malak A, Robin M, Prunet E, Leclercq F, Pasquie JL, Papinaud L, Mercier G, Ricci JE, Cayla G, Duflos C. PRADOC: A Multicenter Randomized Controlled Trial to Assess the Efficiency of PRADO-IC, a Nationwide Pragmatic Transition Care Management Plan for Hospitalized Patients With Heart Failure in France. J Am Heart Assoc. 2024 Aug 6;13(15):e032931. doi: 10.1161/JAHA.123.032931. Epub 2024 Jul 18.
PubMed 39023055
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PRADO Heart Failure in Occitania
- ClinicalTrials.gov ID
- NCT03396081
- Acronym / sponsor ID
- PRADO-IC / RECHMPL17_0113
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Care pathway, Transition program, Efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 10 Jan 2018 (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.
Patients with heart failure (IC), after hospitalization, have a marked fragility: in France, in the first year, 29% die and 45% are readmitted to IC. Interventions improving the coordination of care providers at the time of discharge from hospitalization were tested; they showed a reduction in readmissions for IC (relative risk (RR) from 0.51 to 0.74) and all-cause mortality (RR 0.75 to 0.87). The Patient Return Program IC (PRADO IC), set up by the Health Insurance, offers assistance in the initiation of outpatient medical monitoring, and a nursing follow-up of 2 to 6 months depending on the patient's severity. The trial of PRADO began in the second half of 2013, and the first evaluation showed that the time to first treatment was significantly shorter, and that the readmissions rate and the 6-month death rate were unchanged.
This study was of epidemiological type, comparative before-elsewhere. The difficulty of controlling for confounders in this type of study limits the scope of these conclusions. The efficacy hypothesis of PRADO IC is therefore always posed in the French context
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRADO-IC | Experimental | Behavioral: PRADO-IC |
| Usual care | Other | Behavioral: No intervervention Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Hospitalization for heart failure
- Subject living at home
- Informed consent
Key exclusion criteria (12 listed)
- discharge to a rehabilitation clinic or to medical home for elderly people
- subject without health insurance
- terminal kidney failure
- programmed heart surgery
- waiting for heart transplantation
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 |
|---|---|---|
| PRADO-IC1. Help of administrative employees to schedule the first medical visits after an hospitalization for heart failure. 2. Home nurse's visiting program, during 2 to 6 months after the hospitalization for heart failure. | Behavioural | PRADO-IC |
| No intervervention Usual CareAdvices about the care pathway, provided by care givers. Prescription of home nurse's visits if needed. | Behavioural | Usual care |
Primary outcome
Cost-efficacy ratio
Time frame: 12 months
Cost to avoid an hospitalization for heart failure
6 secondary outcomes
Cost-utility ratio
Time frame: 12 months
Number of hospitalization for heart failure
Time frame: 12 months
Number of all causes hospitalization
Time frame: 12 months
Rate of death from cardiovascular disease
Time frame: 12 months
Number of general practitionner
Time frame: 12 months
Number of cardiologist visits
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 39023055Roubille F, Labarre JP, Georger F, Galinier M, Herman F, Berdague P, Nogue E, Petroni T, Delbaere Q, Malak A, Robin M, Prunet E, Leclercq F, Pasquie JL, Papinaud L, Mercier G, Ricci JE, Cayla G, Duflos C. PRADOC: A Multicenter Randomized Controlled Trial to Assess the Efficiency of PRADO-IC, a Nationwide Pragmatic Transition Care Management Plan for Hospitalized Patients With Heart Failure in France. J Am Heart Assoc. 2024 Aug 6;13(15):e032931. doi: 10.1161/JAHA.123.032931. Epub 2024 Jul 18.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRADO-IC in people with Heart Failure, run by University Hospital, Montpellier at 1 site 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cost-efficacy ratio (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396081, which also lists 1 linked publication.
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 30 Sep 2025.