NCT07608926

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
May 2025Jun 2028

Study Start

First participant enrolled

May 28, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 28, 2026

Last Update Submit

May 19, 2026

Conditions

Cardiovascular (CV) Risk

Keywords

Cardiovascular risk factorsPrevention

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    Systolic and diastolic in millimeters of mercury

    12 months

  • number of cigarettes

    24 months

Secondary Outcomes (2)

  • body weigh

    24 months

  • number of daily steps

    24 months

Study Arms (2)

Digital technology

EXPERIMENTAL

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

Other: Recommendations to the patient.

on site

OTHER

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

Other: Recommendations to the patient.

Interventions

Recommendations to the patient.OTHER

Recommendations to the patient

Digital technologyon site

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 27, 2026

Study Start

May 28, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

May 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)