Cardiovascular Risk FactorsCV-RISKNCT07447362
Clinical Management of Cardiovascular Risk Factors in Adult Patients: A Before-and-After Interventional Study
A study testing Structured Cardiovascular Risk Management in people with Cardiovascular Risk Factors and Hypertension, run by Universidad Católica San Antonio de Murcia at 1 site in Chile.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk Factors, Hypertension, Dyslipidemia
- What is being tested?
- Structured Cardiovascular Risk Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChile
- Study dates
- 24 Jul 2024to 24 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe clinical instability requiring hospitalization
- Pregnancy
- End-stage renal disease or dialysis
- Inability to complete follow-up visits
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
CDIEM Medical Center - Outpatient Cardiology Clinic
Santiago, Santiago Metropolitan
Julio César Núñez Farías, MD, MSc, +56965860130, llaillai@yahoo.es
Julio C Núñez Farías, MD, MSc
About this study
Official 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
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.
- Conditions
- Cardiovascular Risk Factors, Hypertension, Dyslipidemia, Type 2 Diabetes Mellitus, Obesity, Overweight
- Being tested
- Structured Cardiovascular Risk Management
- Keywords
- Cardiovascular prevention, Risk factor control, Medication adherence, Clinical follow-up
- Medical subject headings
- Hypertension, Dyslipidemias, Diabetes Mellitus, Type 2, Obesity, Overweight, Tobacco Use, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Cardiovascular Risk ManagementOther
Protocol-based clinical management including periodic evaluation and adjustment of antihypertensive, lipid-lowering, antidiabetic, and lifestyle interventions according to routine clinical practice guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Structured Clinical Management | Experimental | 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. Receives: Other: Structured Cardiovascular Risk Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
Change in systolic blood pressure (mmHg) measured under standardized conditions to evaluate the effect of structured clinical and pharmacological cardiovascular risk management.
Measured: Baseline to 90 days
Secondary outcomes (11)
Change in diastolic blood pressure
Evaluation of changes in diastolic blood pressure following structured clinical and pharmacological management.
Measured: Baseline to 90 days
Change in LDL cholesterol
Evaluation of changes in LDL cholesterol measured during routine laboratory assessment after structured cardiovascular risk management.
Measured: Baseline to 90 days
Change in HbA1c
Evaluation of changes in glycated hemoglobin (HbA1c) following structured cardiovascular risk management.
Measured: Baseline to 90 days
Change in body weight
Evaluation of changes in body weight following lifestyle counseling and structured cardiovascular risk management.
Measured: Baseline to 90 days
Change in renal function (eGFR)
Evaluation of changes in renal function assessed by estimated glomerular filtration rate following structured cardiovascular risk management.
Measured: Baseline to 90 days
Change in HDL cholesterol
Evaluation of changes in HDL cholesterol measured during routine laboratory assessment after structured cardiovascular risk management.
Measured: Baseline to 90 days
Change in triglycerides
Evaluation of changes in triglyceride levels measured during routine laboratory assessment after structured cardiovascular risk management.
Measured: Baseline to 90 days
Change in total cholesterol
Evaluation of changes in total cholesterol measured during routine laboratory assessment after structured cardiovascular risk management.
Measured: Baseline to 90 days
Change in fasting plasma glucose
Evaluation of changes in fasting plasma glucose following structured cardiovascular risk management.
Measured: Baseline to 90 days
Change in body mass index
Evaluation of changes in body mass index following lifestyle counseling and structured cardiovascular risk management.
Measured: Baseline to 90 days
Change in microalbuminuria
Evaluation of changes in urinary albumin excretion to assess microalbuminuria during follow-up after structured cardiovascular risk management.
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start24 Jul 2024
- Primary completion24 Jul 2026 (estimated)
- Study completion24 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants receive structured clinical follow-up with periodic evaluation and adjustment of standard pharmacological therapy under routine clinical practice using a before-and-after design.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio Núñez Farías, Universidad Católica San Antonio de Murcia
- Investigators
- José Abellán Alemán, MD, PhD, Study chair, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447362
- Sponsor's protocol ID
- UCAM-CVRISK-2024
- Acronym
- CV-RISK
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07447362
- Acronym / sponsor ID
- CV-RISK / UCAM-CVRISK-2024
- Conditions
- Cardiovascular Risk Factors, Hypertension, Dyslipidemia, Type 2 Diabetes Mellitus, Obesity, Overweight
- Keywords
- Cardiovascular prevention, Risk factor control, Medication adherence, Clinical follow-up
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 24 Oct 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants receive structured clinical follow-up with periodic evaluation and adjustment of standard pharmacological therapy under routine clinical practice using a before-and-after design.
| Arm | Type | Receives |
|---|---|---|
| Structured Clinical Management | Experimental | Other: Structured Cardiovascular Risk ManagementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Severe clinical instability requiring hospitalization
- Pregnancy
- End-stage renal disease or dialysis
- Inability to complete follow-up visits
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Cardiovascular Risk ManagementProtocol-based clinical management including periodic evaluation and adjustment of antihypertensive, lipid-lowering, antidiabetic, and lifestyle interventions according to routine clinical practice guidelines. | Other | Structured Clinical Management |
Primary outcome
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.
11 secondary outcomes
Change in diastolic blood pressure
Time frame: Baseline to 90 days
Change in LDL cholesterol
Time frame: Baseline to 90 days
Change in HbA1c
Time frame: Baseline to 90 days
Change in body weight
Time frame: Baseline to 90 days
Change in renal function (eGFR)
Time frame: Baseline to 90 days
Change in HDL cholesterol
Time frame: Baseline to 90 days
Change in triglycerides
Time frame: Baseline to 90 days
Change in total cholesterol
Time frame: Baseline to 90 days
Change in fasting plasma glucose
Time frame: Baseline to 90 days
Change in body mass index
Time frame: Baseline to 90 days
Change in microalbuminuria
Time frame: Baseline to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José Abellán Alemán, MD, PhD study chair
Universidad Católica San Antonio de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Cardiovascular Risk Management in people with Cardiovascular Risk Factors and Hypertension, run by Universidad Católica San Antonio de Murcia at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julio César Núñez Farías, MD, MSc (Cardiology) (+56965860130, llaillai@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (time frame: Baseline to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.