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NCT Number: NCT07447362

Clinical Management of Cardiovascular Risk Factors in Adult Patients: A Before-and-After Interventional 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.

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Key information

Conditions

Cardiovascular Risk Factors Behavior Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Hypertension Lipid Metabolism Disorders Medication Adherence Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Tobacco Use Treatment Adherence and Compliance Type 2 Diabetes Mellitus Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CDIEM Medical Center - Outpatient Cardiology Clinic

Santiago, Santiago Metropolitan, Chile

Location status: Recruiting

Location contact

Julio C Núñez Farías, MD, MSc

PRINCIPAL_INVESTIGATOR

Julio César Núñez Farías, MD, MSc

CONTACT

[email protected]

+56965860130

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Cardiovascular Risk Management

Other

Protocol-based clinical management including periodic evaluation and adjustment of antihypertensive, lipid-lowering, antidiabetic, and lifestyle interventions according to routine clinical practice guidelines.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in diastolic blood pressure

    Time frame: Baseline to 90 days

    Evaluation of changes in diastolic blood pressure following structured clinical and pharmacological management.

  2. 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.

  3. Change in HbA1c

    Time frame: Baseline to 90 days

    Evaluation of changes in glycated hemoglobin (HbA1c) following structured cardiovascular risk management.

  4. Change in body weight

    Time frame: Baseline to 90 days

    Evaluation of changes in body weight following lifestyle counseling and structured cardiovascular risk management.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Change in fasting plasma glucose

    Time frame: Baseline to 90 days

    Evaluation of changes in fasting plasma glucose following structured cardiovascular risk management.

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julio César Núñez Farías, MD, MSc (Cardiology)

CONTACT

[email protected]

+56965860130

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Acronym: CV-RISK

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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