Clinical Management of Cardiovascular Risk Factors in Adult Patients: A Before-and-After Interventional Study (CV-RISK)

February 27, 2026 updated by: Julio Núñez Farías, Universidad Católica San Antonio de Murcia

Effect of a Structured Clinical and Pharmacological Management Strategy on Cardiovascular Risk Factors in Adult Patients in Routine Clinical Practice: A Pseudo-Experimental Before-and-After Study

This study aims to evaluate cardiovascular risk factors, clinical characteristics, and outcomes in adult patients attending an outpatient cardiology clinic. The research focuses on identifying predictors of adverse cardiovascular events, optimizing risk stratification, and improving preventive strategies in routine clinical practice. Data will be collected from patients receiving standard cardiology care without altering their treatment. The results are expected to contribute to better understanding of cardiovascular risk profiles and to support improvements in clinical decision-making and patient management.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Julio César Núñez Farías, MD, MSc (Cardiology)
  • Phone Number: +56965860130
  • Email: llaillai@yahoo.es

Study Locations

  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile
        • Recruiting
        • CDIEM Medical Center - Outpatient Cardiology Clinic
        • Contact:
          • Julio César Núñez Farías, MD, MSc
          • Phone Number: +56965860130
          • Email: llaillai@yahoo.es
        • Principal Investigator:
          • Julio C Núñez Farías, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Presence of at least one cardiovascular risk factor (hypertension, diabetes, dyslipidemia, obesity, or smoking)
  • Receiving outpatient clinical follow-up
  • Ability to provide informed consent

Exclusion Criteria:

  • Severe clinical instability requiring hospitalization
  • Pregnancy
  • End-stage renal disease or dialysis
  • Inability to complete follow-up visits
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured Clinical Management
Participants receive structured clinical follow-up with periodic assessment of cardiovascular risk factors and adjustment of pharmacological and lifestyle management according to current clinical guidelines over a 120-day follow-up period.
Other: Structured Cardiovascular Risk Management
Protocol-based clinical management including periodic evaluation and adjustment of antihypertensive, lipid-lowering, antidiabetic, and lifestyle interventions according to routine clinical practice guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systolic blood pressure
Time Frame: Baseline to 90 days
Change in systolic blood pressure (mmHg) measured under standardized conditions to evaluate the effect of structured clinical and pharmacological cardiovascular risk management.
Baseline to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in diastolic blood pressure
Time Frame: Baseline to 90 days
Evaluation of changes in diastolic blood pressure following structured clinical and pharmacological management.
Baseline to 90 days
Change in LDL cholesterol
Time Frame: Baseline to 90 days
Evaluation of changes in LDL cholesterol measured during routine laboratory assessment after structured cardiovascular risk management.
Baseline to 90 days
Change in HbA1c
Time Frame: Baseline to 90 days
Evaluation of changes in glycated hemoglobin (HbA1c) following structured cardiovascular risk management.
Baseline to 90 days
Change in body weight
Time Frame: Baseline to 90 days
Evaluation of changes in body weight following lifestyle counseling and structured cardiovascular risk management.
Baseline to 90 days
Change in renal function (eGFR)
Time Frame: Baseline to 90 days
Evaluation of changes in renal function assessed by estimated glomerular filtration rate following structured cardiovascular risk management.
Baseline to 90 days
Change in HDL cholesterol
Time Frame: Baseline to 90 days
Evaluation of changes in HDL cholesterol measured during routine laboratory assessment after structured cardiovascular risk management.
Baseline to 90 days
Change in triglycerides
Time Frame: Baseline to 90 days
Evaluation of changes in triglyceride levels measured during routine laboratory assessment after structured cardiovascular risk management.
Baseline to 90 days
Change in total cholesterol
Time Frame: Baseline to 90 days
Evaluation of changes in total cholesterol measured during routine laboratory assessment after structured cardiovascular risk management.
Baseline to 90 days
Change in fasting plasma glucose
Time Frame: Baseline to 90 days
Evaluation of changes in fasting plasma glucose following structured cardiovascular risk management.
Baseline to 90 days
Change in body mass index
Time Frame: Baseline to 90 days
Evaluation of changes in body mass index following lifestyle counseling and structured cardiovascular risk management.
Baseline to 90 days
Change in microalbuminuria
Time Frame: Baseline to 90 days
Evaluation of changes in urinary albumin excretion to assess microalbuminuria during follow-up after structured cardiovascular risk management.
Baseline to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica San Antonio de Murcia

Investigators

  • Study Chair: José Abellán Alemán, MD, PhD, Universidad Católica San Antonio de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2024

Primary Completion (Estimated)

July 24, 2026

Study Completion (Estimated)

October 24, 2026

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCAM-CVRISK-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy regulations and institutional data protection policies. De-identified aggregated results will be available through scientific publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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