Heart FailureCOMPICNCT03902028
Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure
A study testing Reinforced multidisciplinary follow-up in people with Heart Failure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This is a controlled, randomized, open-label, multicentric study evaluating the value of coordinated medico-pharmaceutical management compared to standard management in patients with heart failure. 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?
- Reinforced multidisciplinary follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2019to 25 Jan 2025
- 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
- Patient aged more than 18 years
- Adult patient admitted in cardiology department (full hospitalisation or intensive care) for heart failure no matter the type and the stage of the disease
- Person affiliated or beneficiary of a social security system
- Collection of a free, informed, express and written consent
Who cannot join
- Non autonomous drug management patients and not disposing
- a present caregiver during hospitalisation
- Patients living in an institution
- Person participating in another clinical trial with an exclusion period still ongoing
- Person whose physical and/or psychological health is severely altered, and which, in the opinion of the investigator, may affect the participation's to the study
- Person deprived of his rights, person under tutorship or guardianship
- Refusal to sign the consent
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals
Montpellier, Occitanie, 34295
About this study
Official title: Interest of an Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure: Controlled, Randomized, Multicentric Study
This is a controlled, randomized, open-label, multicentric study evaluating the value of coordinated medico-pharmaceutical management compared to standard management in patients with heart failure. The aim of this study is to evaluate the impact of these optimized activities on the re-hospitalization of the patient with cardiac insufficiency for a disease-related event within three months of the initial hospitalization.
Read the detailed description
Heart failure (FH) is a public health problem with an estimated prevalence of about 1.5% in developed countries. In 2013, the number of patients hospitalized in France for heart failure amounted to 165 231 and 20% of them were re-hospitalized at least once for the same reason during this year. Several factors contribute to the occurrence of cardiac decompensation (DC) : some modifiable (age, severity of IC, etiology ...) and others modifiable, such as therapeutics. Various elements could reduce the frequency of re-hospitalizations and the mortality due to this disease :
- a better knowledge of treatments by patients and consequently a better therapeutic compliance
- a better knowledge of the factors and signs of DC (low-sodium diet, weighing...)
- a better implementation of prescribing recommendations : less than 50% of patients have optimal treatment compared to ESC recommendations
- a better communication at the transition points of the patient pathway. The creation of a binomial cardiologist-clinical pharmacist during hospitalization and the maintenance of this optimized multidisciplinary follow-up within 3 months post-hospitalization is a proposal to intervene on these factors. Indeed, the clinical pharmacist (present in the care unit) works in collaboration with the medical and paramedical teams and can improve the care of patients. In the experimental group, a specific multidisciplinary consultation is planned for one month after the end of the hospitalization. A 3-month follow-up visit will be carried out by phone call to meet the criteria for readmission, mortality, quality of life, adherence and persistence of treatments.
- Conditions
- Heart Failure
- Being tested
- Reinforced multidisciplinary follow-up
- Keywords
- Heart failure, pharmacist, multidisciplinary team, readmission
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforced multidisciplinary follow-upOther
Reinforced multidisciplinary follow-up
| Study group | Role | What they receive |
|---|---|---|
| Reinforced multidisciplinary follow-up | Experimental | Entrance medication reconciliation performed by a pharmacist
* Patient compliance evaluation
* Patient quality of life evaluation
* Pharmaceutical analysis with focus on medication optimization with a specific check-list (according to ESC 2016 recommendations)
* Hospitalisation discharge medication reconciliation
* Patient pharmaceutic interview at the hospitalisation discharge
* Transmission of informations to the general practitioner and the pharmacist's patient
* Multidisciplinary consult at 1 month after hospitalisation discharge Receives: Other: Reinforced multidisciplinary follow-up |
| Standard care | No intervention | * Drug review by a paramedic or a pharmacist * Pharmaceutical analysis * Therapeutic optimisation based on the usual practices care of the cardiologic department * Writing of the prescription given on leaving hospital based on the usual care of the department * Treatments explanations and support to the patient on the usual care * Transmission of the hospitalisation report to the patient general practitioner as the usual practice * Medical consult in usual time frames (an average of 1 month after hospitalisation discharge) at the patient location of choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalisation for heart failure
At least one rehospitalisation with heart failure related cause
Measured: Call at 3 months after hospitalisation discharge
Secondary outcomes (13)
Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016
Evaluated by a pharmacist
Measured: At hospitalisation discharge (Day 0)
Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016
Evaluated by a pharmacist
Measured: Call at 3 months after hospitalisation discharge
Compliance level
Evaluated by the " Girerd medication adherence questionnaire "
The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following :
0 yes : good compliance
1 or 2 yes : minor non compliance 3 or more yes : non compliance
Measured: At hospitalisation discharge (Day 0)
Compliance level
Evaluated by the "Girerd medication adherence questionnaire" Evaluated by the " Girerd medication adherence questionnaire "
The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following :
0 yes : good compliance
1 or 2 yes : minor non compliance 3 or more yes : non compliance
Measured: At 1 month after hospitalisation discharge for the experimental group only
Compliance level
Evaluated by the "Girerd medication adherence questionnaire" Evaluated by the " Girerd medication adherence questionnaire "
The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following :
0 yes : good compliance
1 or 2 yes : minor non compliance 3 or more yes : non compliance
Measured: Call at 3 months after hospitalisation discharge
Treatment persistence rates
Evaluated by a pharmacist
Measured: Call at 3 months after hospitalisation discharge
Death rate
Evaluated by a pharmacist
Measured: Call at 3 months after hospitalisation discharge
Time before death
Evaluated by a pharmacist
Measured: Call at 3 months after hospitalisation discharge
Time of occurrence of a potential rehospitalisation related to the disease
Evaluated by a pharmacist
Measured: Call at 3 months after hospitalisation discharge
Quality of life score
Evaluated by the Minnesota Living with Heart Failure Questionnaire the Minnesota Living with Heart Failure Questionnaire contains 21 questions. Each of the 21 questions ask the patients to indicate how much a possible effect of heart failure have affected their ability to live as wanted during the past month using a scale from 0 (not present or no effect), 1 (very little), 2, 3, 4, or 5 (very much).The measurement of heart failure severity is assessed by summing the responses that ranges from 0 to 105.
Measured: Call at 3 months after hospitalisation discharge
Satisfaction of the patient
Evaluated by Likert scale This questionnaire indicates the degree of patient satisfaction using 9 questions which explore the improvement of patient behavior concerning disease and treatment. The measurement of satisfaction is assessed by summing the responses that range from 9 (unsatisfied) to 36 (very satisfied)
Measured: Call at 3 months after hospitalisation discharge
Satisfaction of health professionals
Evaluated by Likert scale (only for interventional arm) This questionnaire indicates the degree of health professional satisfaction using 6 questions which explore the improvement of transition between hospital to community and comprehension of therapeutic optimization. The measurement of satisfaction is assessed by summing the responses that range from 6 (unsatisfied) to 24 (very satisfied)
Measured: online questionnaire at 3 months after hospitalisation discharge
Incremental cost-effectiveness ratio
Measured: 3 months after hospitalisation discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start2 Aug 2019
- Primary completion25 Jan 2025
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 229 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
- NCT03902028
- Sponsor's protocol ID
- RECHMPL18_0040
- Acronym
- COMPIC
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2019
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jackevicius CA, de Leon NK, Lu L, Chang DS, Warner AL, Mody FV. Impact of a Multidisciplinary Heart Failure Post-hospitalization Program on Heart Failure Readmission Rates. Ann Pharmacother. 2015 Nov;49(11):1189-96. doi: 10.1177/1060028015599637. Epub 2015 Aug 10.
PubMed 26259774Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
PubMed 27206819Available at: https://academic.oup.com/eurheartj/article/37/27/2129/1748921/2016-ESC-Guidelines-for-the-diagnosis-and. (Accessed: 12th September 2017).
Masters J, Morton G, Anton I, Szymanski J, Greenwood E, Grogono J, Flett AS, Cleland JG, Cowburn PJ. Specialist intervention is associated with improved patient outcomes in patients with decompensated heart failure: evaluation of the impact of a multidisciplinary inpatient heart failure team. Open Heart. 2017 Mar 8;4(1):e000547. doi: 10.1136/openhrt-2016-000547. eCollection 2017.
PubMed 28409010Van Spall HGC, Rahman T, Mytton O, Ramasundarahettige C, Ibrahim Q, Kabali C, Coppens M, Brian Haynes R, Connolly S. Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure: a systematic review and network meta-analysis. Eur J Heart Fail. 2017 Nov;19(11):1427-1443. doi: 10.1002/ejhf.765. Epub 2017 Feb 24.
PubMed 28233442Lopez Cabezas C, Falces Salvador C, Cubi Quadrada D, Arnau Bartes A, Ylla Bore M, Muro Perea N, Homs Peipoch E. Randomized clinical trial of a postdischarge pharmaceutical care program vs regular follow-up in patients with heart failure. Farm Hosp. 2006 Nov-Dec;30(6):328-42. doi: 10.1016/s1130-6343(06)74004-1. English, Spanish.
PubMed 17298190Parajuli DR, Franzon J, McKinnon RA, Shakib S, Clark RA. Role of the Pharmacist for Improving Self-care and Outcomes in Heart Failure. Curr Heart Fail Rep. 2017 Apr;14(2):78-86. doi: 10.1007/s11897-017-0323-2.
PubMed 28233258Wan TTH, Terry A, Cobb E, McKee B, Tregerman R, Barbaro SDS. Strategies to Modify the Risk of Heart Failure Readmission: A Systematic Review and Meta-Analysis. Health Serv Res Manag Epidemiol. 2017 Apr 18;4:2333392817701050. doi: 10.1177/2333392817701050. eCollection 2017 Jan-Dec.
PubMed 28462286Buckley MS, Harinstein LM, Clark KB, Smithburger PL, Eckhardt DJ, Alexander E, Devabhakthuni S, Westley CA, David B, Kane-Gill SL. Impact of a clinical pharmacy admission medication reconciliation program on medication errors in "high-risk" patients. Ann Pharmacother. 2013 Dec;47(12):1599-610. doi: 10.1177/1060028013507428. Epub 2013 Oct 15.
PubMed 24259613Warden BA, Freels JP, Furuno JP, Mackay J. Pharmacy-managed program for providing education and discharge instructions for patients with heart failure. Am J Health Syst Pharm. 2014 Jan 15;71(2):134-9. doi: 10.2146/ajhp130103.
PubMed 24375606
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of an Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure: Controlled, Randomized, Multicentric Study
- ClinicalTrials.gov ID
- NCT03902028
- Acronym / sponsor ID
- COMPIC / RECHMPL18_0040
- Conditions
- Heart Failure
- Keywords
- Heart failure, pharmacist, multidisciplinary team, readmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 3 Apr 2019 (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.
This is a controlled, randomized, open-label, multicentric study evaluating the value of coordinated medico-pharmaceutical management compared to standard management in patients with heart failure. The aim of this study is to evaluate the impact of these optimized activities on the re-hospitalization of the patient with cardiac insufficiency for a disease-related event within three months of the initial hospitalization.
Detailed description
Heart failure (FH) is a public health problem with an estimated prevalence of about 1.5% in developed countries. In 2013, the number of patients hospitalized in France for heart failure amounted to 165 231 and 20% of them were re-hospitalized at least once for the same reason during this year. Several factors contribute to the occurrence of cardiac decompensation (DC) : some modifiable (age, severity of IC, etiology ...) and others modifiable, such as therapeutics. Various elements could reduce the frequency of re-hospitalizations and the mortality due to this disease :
- a better knowledge of treatments by patients and consequently a better therapeutic compliance
- a better knowledge of the factors and signs of DC (low-sodium diet, weighing...)
- a better implementation of prescribing recommendations : less than 50% of patients have optimal treatment compared to ESC recommendations
- a better communication at the transition points of the patient pathway. The creation of a binomial cardiologist-clinical pharmacist during hospitalization and the maintenance of this optimized multidisciplinary follow-up within 3 months post-hospitalization is a proposal to intervene on these factors. Indeed, the clinical pharmacist (present in the care unit) works in collaboration with the medical and paramedical teams and can improve the care of patients. In the experimental group, a specific multidisciplinary consultation is planned for one month after the end of the hospitalization. A 3-month follow-up visit will be carried out by phone call to meet the criteria for readmission, mortality, quality of life, adherence and persistence of treatments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinforced multidisciplinary follow-up | Experimental | Other: Reinforced multidisciplinary follow-upEntrance medication reconciliation performed by a pharmacist * Patient compliance evaluation * Patient quality of life evaluation * Pharmaceutical analysis with focus on medication optimization with a specific check-list (according to ESC 2016 recommendations) * Hospitalisation discharge medication reconciliation * Patient pharmaceutic interview at the hospitalisation discharge * Transmission of informations to the general practitioner and the pharmacist's patient * Multidisciplinary consult at 1 month after hospitalisation discharge |
| Standard care | No intervention | –* Drug review by a paramedic or a pharmacist * Pharmaceutical analysis * Therapeutic optimisation based on the usual practices care of the cardiologic department * Writing of the prescription given on leaving hospital based on the usual care of the department * Treatments explanations and support to the patient on the usual care * Transmission of the hospitalisation report to the patient general practitioner as the usual practice * Medical consult in usual time frames (an average of 1 month after hospitalisation discharge) at the patient location of choice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged more than 18 years
- Adult patient admitted in cardiology department (full hospitalisation or intensive care) for heart failure no matter the type and the stage of the disease
- Person affiliated or beneficiary of a social security system
- Collection of a free, informed, express and written consent
Key exclusion criteria (7 listed)
- Non autonomous drug management patients and not disposing
- a present caregiver during hospitalisation
- Patients living in an institution
- Person participating in another clinical trial with an exclusion period still ongoing
- Person whose physical and/or psychological health is severely altered, and which, in the opinion of the investigator, may affect the participation's to the study
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 |
|---|---|---|
| Reinforced multidisciplinary follow-upReinforced multidisciplinary follow-up | Other | Reinforced multidisciplinary follow-up |
Primary outcome
Rehospitalisation for heart failure
Time frame: Call at 3 months after hospitalisation discharge
At least one rehospitalisation with heart failure related cause
13 secondary outcomes
Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016
Time frame: At hospitalisation discharge (Day 0)
Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016
Time frame: Call at 3 months after hospitalisation discharge
Compliance level
Time frame: At hospitalisation discharge (Day 0)
Compliance level
Time frame: At 1 month after hospitalisation discharge for the experimental group only
Compliance level
Time frame: Call at 3 months after hospitalisation discharge
Treatment persistence rates
Time frame: Call at 3 months after hospitalisation discharge
Death rate
Time frame: Call at 3 months after hospitalisation discharge
Time before death
Time frame: Call at 3 months after hospitalisation discharge
Time of occurrence of a potential rehospitalisation related to the disease
Time frame: Call at 3 months after hospitalisation discharge
Quality of life score
Time frame: Call at 3 months after hospitalisation discharge
Satisfaction of the patient
Time frame: Call at 3 months after hospitalisation discharge
Satisfaction of health professionals
Time frame: online questionnaire at 3 months after hospitalisation discharge
Incremental cost-effectiveness ratio
Time frame: 3 months after hospitalisation discharge
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 3 Apr 2026.
- Results publication: PubMed 26259774Jackevicius CA, de Leon NK, Lu L, Chang DS, Warner AL, Mody FV. Impact of a Multidisciplinary Heart Failure Post-hospitalization Program on Heart Failure Readmission Rates. Ann Pharmacother. 2015 Nov;49(11):1189-96. doi: 10.1177/1060028015599637. Epub 2015 Aug 10.
- Results publication: PubMed 27206819Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
- Results publicationAvailable at: https://academic.oup.com/eurheartj/article/37/27/2129/1748921/2016-ESC-Guidelines-for-the-diagnosis-and. (Accessed: 12th September 2017).
- Results publication: PubMed 28409010Masters J, Morton G, Anton I, Szymanski J, Greenwood E, Grogono J, Flett AS, Cleland JG, Cowburn PJ. Specialist intervention is associated with improved patient outcomes in patients with decompensated heart failure: evaluation of the impact of a multidisciplinary inpatient heart failure team. Open Heart. 2017 Mar 8;4(1):e000547. doi: 10.1136/openhrt-2016-000547. eCollection 2017.
- Results publication: PubMed 28233442Van Spall HGC, Rahman T, Mytton O, Ramasundarahettige C, Ibrahim Q, Kabali C, Coppens M, Brian Haynes R, Connolly S. Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure: a systematic review and network meta-analysis. Eur J Heart Fail. 2017 Nov;19(11):1427-1443. doi: 10.1002/ejhf.765. Epub 2017 Feb 24.
- Results publication: PubMed 17298190Lopez Cabezas C, Falces Salvador C, Cubi Quadrada D, Arnau Bartes A, Ylla Bore M, Muro Perea N, Homs Peipoch E. Randomized clinical trial of a postdischarge pharmaceutical care program vs regular follow-up in patients with heart failure. Farm Hosp. 2006 Nov-Dec;30(6):328-42. doi: 10.1016/s1130-6343(06)74004-1. English, Spanish.
- Results publication: PubMed 28233258Parajuli DR, Franzon J, McKinnon RA, Shakib S, Clark RA. Role of the Pharmacist for Improving Self-care and Outcomes in Heart Failure. Curr Heart Fail Rep. 2017 Apr;14(2):78-86. doi: 10.1007/s11897-017-0323-2.
- Results publication: PubMed 28462286Wan TTH, Terry A, Cobb E, McKee B, Tregerman R, Barbaro SDS. Strategies to Modify the Risk of Heart Failure Readmission: A Systematic Review and Meta-Analysis. Health Serv Res Manag Epidemiol. 2017 Apr 18;4:2333392817701050. doi: 10.1177/2333392817701050. eCollection 2017 Jan-Dec.
- Results publication: PubMed 24259613Buckley MS, Harinstein LM, Clark KB, Smithburger PL, Eckhardt DJ, Alexander E, Devabhakthuni S, Westley CA, David B, Kane-Gill SL. Impact of a clinical pharmacy admission medication reconciliation program on medication errors in "high-risk" patients. Ann Pharmacother. 2013 Dec;47(12):1599-610. doi: 10.1177/1060028013507428. Epub 2013 Oct 15.
- Results publication: PubMed 24375606Warden BA, Freels JP, Furuno JP, Mackay J. Pharmacy-managed program for providing education and discharge instructions for patients with heart failure. Am J Health Syst Pharm. 2014 Jan 15;71(2):134-9. doi: 10.2146/ajhp130103.
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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.
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 Reinforced multidisciplinary follow-up 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 7 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 3 Apr 2026. 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?
Rehospitalisation for heart failure (time frame: Call at 3 months after hospitalisation discharge). 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 NCT03902028, which also lists 10 linked publications.
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 3 Apr 2026.