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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Católica San Antonio de Murcia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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