Heart FailureAZIMUSANCT07022067
EVOLVING AZIMUTH IN MUSA CONTEXT
A study testing Telemonitoring app in people with Heart Failure and Blood Pressure, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Non-pharmacological, randomized, nonprofit medical device intervention. The study aims to identify the positive impacts (co-creation), and negative impacts (co-destruction), resulting from the use of telemedicine, and, in particular, the telemonitoring service for 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, Blood Pressure, Weight Change
- What is being tested?
- Telemonitoring app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteItaly
- Study dates
- 2 Oct 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Have been diagnosed with chronic CS according to the ESC guidelines;
- Over 18 years of age;
- Patients admitted to hospital or with access to first aid within the last year;
- Smartphome that meets the digital requirements (ie Android or iOS able to download and use the application);
- Wi-Fi or 3G coverage at home;
- Ability to give written informed consent.
Who cannot join
- Severe psychiatric disorder
- Inability to use portable technologies
- Patients unable to use the equipment provided
- Patients who deny consent to study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Prof. Carugo, +390255033532, stefano.carugo@policlinico.mi.it
About this study
Non-pharmacological, randomized, nonprofit medical device intervention. The study aims to identify the positive impacts (co-creation), and negative impacts (co-destruction), resulting from the use of telemedicine, and, in particular, the telemonitoring service for patients with heart failure
Read the detailed description
The patient diagnosed with heart failure is randomized to either the experimental or control arm. The patient in the experimental arm downloads a telemonitoring application where they enter their pressure and body weight data, which is revised by the hospital team via a platform. Patients from both arms complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions.
- Conditions
- Heart Failure, Blood Pressure, Weight Change, Telemonitoring
- Being tested
- Telemonitoring app
- Medical subject headings
- Heart Failure, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring appDevice
periodic measurement of blood pressure and body weight
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | The patient in the experimental arm downloads a telemonitoring application where they enter their pressure and body weight data, which is revised by the hospital team via a platform. The patient complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions. Receives: Device: Telemonitoring app |
| Standard care | No intervention | The patient in the standard care arm do not downloads a telemonitoring application, but they continue with normal medical indication. The patient complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAM13-I
The Patient Activation Measure (PAM13-I) is a brief, validated instrument that assesses patient knowledge, skills, and confidence for disease self-management. It consists of 13 items on a Likert scale. According to the American version of PAM 13, each item has five response categories with scores from 1 to 5: (1) "Strongly Disagree", (2) "Disagree", (3) "Agree", (4) "Strongly Agree" and (5) "Not Applicable". The instrument design reflects the four stages of activation in a progressing difficulty of the items: level 1 (patients believe that their role is important: items 1 and 2), level 2 (patients have confidence and knowledge to take action: items 3-8) level 3 (taking action: items 9-11) and level 4 (staying on course under stress: items 12 and 13).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start2 Oct 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Collaborators
- ASST Grande Ospedale Metropolitano Niguarda, University of Milan
- Responsible party
- Principal investigator, Stefano Carugo, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Stefano Prof. Carugo, Principal investigator, IRCCS Fondazione Caì Granda Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022067
- Sponsor's protocol ID
- 4372
- Acronym
- AZIMUSA
- Status last verified
- Jun 2025
- First submitted
- 14 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVOLVING AZIMUTH IN MUSA CONTEXT
- ClinicalTrials.gov ID
- NCT07022067
- Acronym / sponsor ID
- AZIMUSA / 4372
- Conditions
- Heart Failure, Blood Pressure, Weight Change, Telemonitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- ASST Grande Ospedale Metropolitano Niguarda, University of Milan
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 15 Jun 2025 (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.
Non-pharmacological, randomized, nonprofit medical device intervention. The study aims to identify the positive impacts (co-creation), and negative impacts (co-destruction), resulting from the use of telemedicine, and, in particular, the telemonitoring service for patients with heart failure
Detailed description
The patient diagnosed with heart failure is randomized to either the experimental or control arm. The patient in the experimental arm downloads a telemonitoring application where they enter their pressure and body weight data, which is revised by the hospital team via a platform. Patients from both arms complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Device: Telemonitoring appThe patient in the experimental arm downloads a telemonitoring application where they enter their pressure and body weight data, which is revised by the hospital team via a platform. The patient complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions. |
| Standard care | No intervention | –The patient in the standard care arm do not downloads a telemonitoring application, but they continue with normal medical indication. The patient complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have been diagnosed with chronic CS according to the ESC guidelines;
- Over 18 years of age;
- Patients admitted to hospital or with access to first aid within the last year;
- Smartphome that meets the digital requirements (ie Android or iOS able to download and use the application);
- Wi-Fi or 3G coverage at home;
Key exclusion criteria (4 listed)
- Severe psychiatric disorder
- Inability to use portable technologies
- Patients unable to use the equipment provided
- Patients who deny consent to study participation
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 |
|---|---|---|
| Telemonitoring appperiodic measurement of blood pressure and body weight | Device | Telemonitoring |
Primary outcome
PAM13-I
Time frame: 6 months
The Patient Activation Measure (PAM13-I) is a brief, validated instrument that assesses patient knowledge, skills, and confidence for disease self-management. It consists of 13 items on a Likert scale. According to the American version of PAM 13, each item has five response categories with scores from 1 to 5: (1) "Strongly Disagree", (2) "Disagree", (3) "Agree", (4) "Strongly Agree" and (5) "Not Applicable". The instrument design reflects the four stages of activation in a progressing difficulty of the items: level 1 (patients believe that their role is important: items 1 and 2), level 2 (patients have confidence and knowledge to take action: items 3-8) level 3 (taking action: items 9-11) and level 4 (staying on course under stress: items 12 and 13).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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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.
Stefano Prof. Carugo principal investigator
IRCCS Fondazione Caì Granda Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring app in people with Heart Failure and Blood Pressure, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Jun 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Prof. Carugo (+390255033532, stefano.carugo@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAM13-I (time frame: 6 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 15 Jun 2025.