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RecruitingNCT07608926DIGITAL PREVUpdated May 27, 2026

Cardiovascular Prevention Supported by Digital Technology: Comparison With the Traditional Model

An interventional study of Recommendations to the patient. in Cardiovascular (CV) Risk, sponsored by Maria Cecilia Hospital. Recruiting at 1 site in Italy. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Maria Cecilia Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cardiovascular (CV) Risk

Keywords

  • Cardiovascular risk factors
  • Prevention
03

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • previous myocardial infarction
  • stroke
  • transient ischemic attack
  • coronary artery diseas
  • peripheral arterial occlusive disease
  • heart failure
  • 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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    Digital technology

    Remote management of study participants, enabling the structured collection of relevant information for follow-up.

    Other: Recommendations to the patient.

  • Other
    on site

    adherence to in-person follow-up at the hospital.

    Other: Recommendations to the patient.

Interventions

  • OtherRecommendations to the patient.

    Recommendations to the patient

05

What researchers measure

Primary outcomes

  1. Blood pressure

    Systolic and diastolic in millimeters of mercury

    Time frame: 12 months

  2. number of cigarettes

    Time frame: 24 months

Secondary outcomes

  1. body weigh

    Time frame: 24 months

  2. number of daily steps

    Time frame: 24 months

06

Study locations

1 of 1 sites recruiting
  • Maria Cecilia Hospital
    Cotignola, Ravenna 48033, Italy
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07608926
Lead sponsor
Maria Cecilia Hospital
Responsible party
Sponsor
First posted
May 27, 2026
Start date
May 28, 2025
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
May 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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