Heart FailureAPPLIMONCOEURNCT04198779
Interest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure
A study testing APPLI in people with Heart Failure and Heart Decompensation, run by French Cardiology Society at 16 sites in France.
Trial summary
Heart failure is a chronic disease that requires careful monitoring and therapeutic education. Smartphones have made their appearance in patients lives and allow close contact with them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Decompensation
- What is being tested?
- APPLI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 16 sitesFrance
- Study dates
- 12 Feb 2020to 27 Nov 2023
- 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 hospitalized for acute or decompensated heart failure
- Patient with a smartphone and able to use a digital application
- Beneficiary of a social protection scheme
- Patients benefiting from a telemedicine program can be included
Who cannot join
- Acute coronary syndrome during ongoing hospitalization.
- Acute myocarditis, constrictive pericarditis, acute endocarditis during ongoing hospitalization.
- Isolated right heart failure of respiratory origin.
- Existence of a cause considered rapidly reversible to acute heart failure: tachyarrhythmia, excessive bradycardia, acute anemia, acute renal failure, malignant hypertension, overdose or cardiotoxic drug intoxication.
- Indication of cardiac surgery scheduled within 3 months after hospitalization, patients with Tavi or MItraclip expected within 3 months
- Extracardiac disease with short-term prognosis (progressive neoplasia).
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- Refusal or incapacitation of language or psychic to sign informed consent
- Patients participating in an other biomedical research can not participate in this study for the first 6 months, not to interfere with the consultation process of the study.
- Pregnant or lactating women can't participate in the study.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
CHU Amiens - Picardie - Site Sud
Amiens, 80054
Hospices Civils de Lyon
Bron, 69677
CHU Henri Mondor
Créteil, 94010
CHU de Grenoble
Grenoble, 38043
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
CHRU de Lille
Lille, 59037
Groupe Hospitalier Sud Ile de France
Melun, 77000
CHU Arnaud de Villeneuve
Montpellier, 34295
Hôpital Lariboisière
Paris, 75010
Hôpital Universitaire Pitié Salpêtrière
Paris, 75651
Hôpital Européen Georges Pompidou
Paris, 75908
CHU de Poitiers
Poitiers, 86021
CHU de ROUEN - Hôpital Charles Nicolle
Rouen, 76031
CHRU de Strasbourg
Strasbourg, 67091
Hôpital Sainte Musse de Toulon
Toulon, 83100
CHU de Toulouse
Toulouse, 31059
About this study
Heart failure is a chronic disease that requires careful monitoring and therapeutic education. Smartphones have made their appearance in patients lives and allow close contact with them. The possibility of using a digital application dedicated to patients with heart failure concerning the symptoms to be monitored, treatments, diet, appointments, physical activity could improve the monitoring and the prognosis of patients following their hospitalization.
Read the detailed description
The aim of this study is to demonstrate that the use of a special application dedicated to the monitoring of heart failures disease has a favorable impact on the occurrence of readmissions and, ultimately, cardiovascular mortality. The aim of this study is also to demonstrate that the use of this "MonCœur" application improves symptoms, quality of life, treatment compliance, diet compliance, and physical activity in patient with heart failure disease.
- Conditions
- Heart Failure, Heart Decompensation
- Being tested
- APPLI
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APPLIDevice
The support with the digital application is including a 10-minutes training about the use of the digital application at the beginning of the study. Patient will have to register information about their Heart failure disease (weight, shortness of breath, fatigue, mood, cardiologist appointments, blood results, ...). During each routine consultation, patients will be encouraged to use the digital app, and the obstacles encountered will be explored and resolved. In addition, participants will receive an email containing relevant information and, every three months, an email reminder of the use of the application.
| Study group | Role | What they receive |
|---|---|---|
| APPLI | Experimental | Care support with implementation of the application Receives: Device: APPLI |
| CONTROL | No intervention | Conventional care support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the use of "MonCoeur" application on the impact of patient health self-care
Comparison between the 2 study arms of the score of the European Heart Failure Self-care Behaviour Scale, consisting of 9 items each evaluated on a 5-point Likert scale, and allowing the calculation of a standardized global score from 0 to 100: the highest score indicating better "self-care".
Measured: 3, 6 and 12 months
Secondary outcomes (6)
Evaluation of the use of "MonCoeur" application on hospitalisation rate
Comparison between the 2 study arms on the number of days without hospitalisation
Measured: 3, 6 and 12 months
Evaluation of the use of "MonCoeur" application on cardiovascular parameters
Comparison between the 2 study arms of Brain Natriuretic Peptid (nanograms / liter)
Measured: 3, 6 and 12 months
Evaluation of the use of "MonCoeur" application on patient compliance
Comparison between the 2 study arms on percentage of appointments scheduled versus appointments honored. Comparison between the 2 study arms of the score of the treatment observance scale Ameli.
Measured: 3, 6 and 12 months
Evaluation of the use of "MonCoeur" application on patient quality of life: Minnesota Living with Heart Failure Questionnaire
Comparison between the 2 study arms of the score of the Minnesota Living with Heart Failure Questionnaire. It provides a total score (range 0-105, from best to worst), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score.
Measured: 3, 6 and 12 months
Evaluation of the use of "MonCoeur" application on patient physical activity
Comparison between the 2 study arms of the score of the Qappa ("questionnaire d'activité physique pour personnes âgées" / translation in english: "physical activity questionnaire for seniors") physical activity questionnaire. The QAPPA uses the calculation system of the volume of physical activity per minute and per week and classified as high, moderate, or low level.
Measured: 3, 6 and 12 months
Describe how often and how the application is used by patients
Calculation of the number and type of parameters filled in the application.
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start12 Feb 2020
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Why it stopped: Low recrutement rate
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.
- 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
- Model description
- Prospective, multicentric, randomized, controlled, open, 2 parallel arms study, in 11 centers.
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle BERTHELOT, MD, Principal investigator, Hôpital Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198779
- Sponsor's protocol ID
- 2019-01
- Acronym
- APPLIMONCOEUR
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2019
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berthelot E, Audureau E, Bouleti C, Duval AJ, Canu M, Itier R, Legrand L, Alloujami M, Tartiere JM, Degroote P, Logeart D, Roubille F, Martin AC, Damy T, Bauer F. Impact of the MonCoeur smartphone application on self-care and quality of life in heart failure: The APPLIMONCOEUR randomized trial. Arch Cardiovasc Dis. 2026 May 15:S1875-2136(26)00208-1. doi: 10.1016/j.acvd.2026.04.007. Online ahead of print.
PubMed 42225494
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT04198779
- Acronym / sponsor ID
- APPLIMONCOEUR / 2019-01
- Conditions
- Heart Failure, Heart Decompensation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recrutement rate
- Enrolment
- 125 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 13 Dec 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.
Heart failure is a chronic disease that requires careful monitoring and therapeutic education. Smartphones have made their appearance in patients lives and allow close contact with them. The possibility of using a digital application dedicated to patients with heart failure concerning the symptoms to be monitored, treatments, diet, appointments, physical activity could improve the monitoring and the prognosis of patients following their hospitalization.
Detailed description
The aim of this study is to demonstrate that the use of a special application dedicated to the monitoring of heart failures disease has a favorable impact on the occurrence of readmissions and, ultimately, cardiovascular mortality. The aim of this study is also to demonstrate that the use of this "MonCœur" application improves symptoms, quality of life, treatment compliance, diet compliance, and physical activity in patient with heart failure disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicentric, randomized, controlled, open, 2 parallel arms study, in 11 centers.
| Arm | Type | Receives |
|---|---|---|
| APPLI | Experimental | Device: APPLICare support with implementation of the application |
| CONTROL | No intervention | –Conventional care support |
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 hospitalized for acute or decompensated heart failure
- Patient with a smartphone and able to use a digital application
- Beneficiary of a social protection scheme
- Patients benefiting from a telemedicine program can be included
Key exclusion criteria (9 listed)
- Acute coronary syndrome during ongoing hospitalization.
- Acute myocarditis, constrictive pericarditis, acute endocarditis during ongoing hospitalization.
- Isolated right heart failure of respiratory origin.
- Existence of a cause considered rapidly reversible to acute heart failure: tachyarrhythmia, excessive bradycardia, acute anemia, acute renal failure, malignant hypertension, overdose or cardiotoxic drug intoxication.
- Indication of cardiac surgery scheduled within 3 months after hospitalization, patients with Tavi or MItraclip expected within 3 months
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 |
|---|---|---|
| APPLIThe support with the digital application is including a 10-minutes training about the use of the digital application at the beginning of the study. Patient will have to register information about their Heart failure disease (weight, shortness of breath, fatigue, mood, cardiologist appointments, blood results, ...). During each routine consultation, patients will be encouraged to use the digital app, and the obstacles encountered will be explored and resolved. In addition, participants will receive an email containing relevant information and, every three months, an email reminder of the use of the application. | Device | APPLI |
Primary outcome
Evaluation of the use of "MonCoeur" application on the impact of patient health self-care
Time frame: 3, 6 and 12 months
Comparison between the 2 study arms of the score of the European Heart Failure Self-care Behaviour Scale, consisting of 9 items each evaluated on a 5-point Likert scale, and allowing the calculation of a standardized global score from 0 to 100: the highest score indicating better "self-care".
6 secondary outcomes
Evaluation of the use of "MonCoeur" application on hospitalisation rate
Time frame: 3, 6 and 12 months
Evaluation of the use of "MonCoeur" application on cardiovascular parameters
Time frame: 3, 6 and 12 months
Evaluation of the use of "MonCoeur" application on patient compliance
Time frame: 3, 6 and 12 months
Evaluation of the use of "MonCoeur" application on patient quality of life: Minnesota Living with Heart Failure Questionnaire
Time frame: 3, 6 and 12 months
Evaluation of the use of "MonCoeur" application on patient physical activity
Time frame: 3, 6 and 12 months
Describe how often and how the application is used by patients
Time frame: 3, 6 and 12 months
Results and safety
The study was stopped early (reason given: Low recrutement rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 42225494Berthelot E, Audureau E, Bouleti C, Duval AJ, Canu M, Itier R, Legrand L, Alloujami M, Tartiere JM, Degroote P, Logeart D, Roubille F, Martin AC, Damy T, Bauer F. Impact of the MonCoeur smartphone application on self-care and quality of life in heart failure: The APPLIMONCOEUR randomized trial. Arch Cardiovasc Dis. 2026 May 15:S1875-2136(26)00208-1. doi: 10.1016/j.acvd.2026.04.007. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Emmanuelle BERTHELOT, MD principal investigator
Hôpital Bicêtre
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APPLI in people with Heart Failure and Heart Decompensation, run by French Cardiology Society at 16 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 4 inclusion and 9 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 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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: Low recrutement rate). 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?
Evaluation of the use of "MonCoeur" application on the impact of patient health self-care (time frame: 3, 6 and 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 NCT04198779, 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 1 Dec 2023.