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Recruiting NCT07608926

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

No phase Interventional Cardiovascular (CV) Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Recommendations to the patient..
Who it may be relevant to
Registry conditions: Cardiovascular (CV) Risk. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Recommendations to the patient.
    Recommendations to the patient

Primary outcome measures

  • Blood pressure [Time frame: 12 months]
  • number of cigarettes [Time frame: 24 months]
Secondary outcome measures (2)
  • body weigh [Time frame: 24 months]
  • number of daily steps [Time frame: 24 months]

Eligibility criteria

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Italy · 1 center
  • Maria Cecilia Hospital — Cotignola

Identifiers

NCT: NCT07608926 · DIGITAL PREV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗