Cardiovascular (CV) RiskDIGITAL PREVNCT07608926
Cardiovascular Prevention Supported by Digital Technology: Comparison With the Traditional Model
A study testing Recommendations to the patient. in people with Cardiovascular (CV) Risk, run by Maria Cecilia Hospital at 1 site in Italy.
Trial summary
Cardiovascular diseases represent one of the leading causes of morbidity and mortality worldwide. Prevention in patients at cardiovascular risk is essential to reduce the incidence of cardiovascular events and slow the progression of risk. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cardiovascular (CV) Risk
- What is being tested?
- Recommendations to the patient.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2025to Jun 2028
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 75 years
- hypertension
- hyperglycaemia
- type 2 diabetes not requiring insulin therapy
- dyslipidaemia
- active smoking
- overweight/grade I obesity
- Willingness to participate in follow-up visits over 24 months
Who cannot join
- previous myocardial infarction
- stroke
- transient ischemic attack
- coronary artery diseas
- peripheral arterial occlusive disease
- heart failure
Show all 12Show fewer
- Type 1 or type 2 diabetes mellitus on insulin therapy
- Advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m²)
- Active cancer disease
- Severe obesity
- Inability to use digital tools
- Pregnancy
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
Maria Cecilia Hospital
Cotignola, Ravenna, 48033
Anna Maria Malagoni, Dr, +390545217213, amalagoni@gvmnet.it
About this study
Cardiovascular diseases represent one of the leading causes of morbidity and mortality worldwide. Prevention in patients at cardiovascular risk is essential to reduce the incidence of cardiovascular events and slow the progression of risk.
This study aims to evaluate the effectiveness and feasibility of a cardiovascular prevention pathway delivered remotely through a digital application, comparing it with a traditional in-person care pathway.
- Conditions
- Cardiovascular (CV) Risk
- Being tested
- Recommendations to the patient.
- Keywords
- Cardiovascular risk factors, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommendations to the patient.Other
Recommendations to the patient
| Study group | Role | What they receive |
|---|---|---|
| Digital technology | Experimental | Remote management of study participants, enabling the structured collection of relevant information for follow-up. Receives: Other: Recommendations to the patient. |
| on site | Other | adherence to in-person follow-up at the hospital. Receives: Other: Recommendations to the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Systolic and diastolic in millimeters of mercury
Measured: 12 months
number of cigarettes
Measured: 24 months
Secondary outcomes (2)
body weigh
Measured: 24 months
number of daily steps
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start28 May 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular (CV) RiskStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608926
- Sponsor's protocol ID
- DIGITAL PREV
- Acronym
- DIGITAL PREV
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 27 May 2026
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Prevention Supported by Digital Technology: Comparison With the Traditional Model
- ClinicalTrials.gov ID
- NCT07608926
- Acronym / sponsor ID
- DIGITAL PREV / DIGITAL PREV
- Conditions
- Cardiovascular (CV) Risk
- Keywords
- Cardiovascular risk factors, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 27 May 2026 (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.
Cardiovascular diseases represent one of the leading causes of morbidity and mortality worldwide. Prevention in patients at cardiovascular risk is essential to reduce the incidence of cardiovascular events and slow the progression of risk.
This study aims to evaluate the effectiveness and feasibility of a cardiovascular prevention pathway delivered remotely through a digital application, comparing it with a traditional in-person care pathway.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital technology | Experimental | Other: Recommendations to the patient.Remote management of study participants, enabling the structured collection of relevant information for follow-up. |
| on site | Other | Other: Recommendations to the patient.adherence to in-person follow-up at the hospital. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 40 and 75 years
- hypertension
- hyperglycaemia
- type 2 diabetes not requiring insulin therapy
- dyslipidaemia
Key exclusion criteria (12 listed)
- previous myocardial infarction
- stroke
- transient ischemic attack
- coronary artery diseas
- peripheral arterial occlusive disease
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 |
|---|---|---|
| Recommendations to the patient.Recommendations to the patient | Other | Digital technology, on site |
Primary outcome
Blood pressure
Time frame: 12 months
Systolic and diastolic in millimeters of mercury
number of cigarettes
Time frame: 24 months
2 secondary outcomes
body weigh
Time frame: 24 months
number of daily steps
Time frame: 24 months
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 27 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recommendations to the patient. in people with Cardiovascular (CV) Risk, run by Maria Cecilia Hospital 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 8 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: looking for participants now, as of the sponsor's last update on 27 May 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 12 months). The study lists 2 primary outcomes in all. 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 27 May 2026.