Hypertension Heart Disease Risk Factors
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older; Hypertension under stable treatment for more than 3 months; At least one additional cardiovascular risk factor (current or former smoking; dyslipidemia, impaired glucose tolerance).
Exclusion criteria
Exclusion criteria: Blood pressure at the screening visit of 140 mmHg or higher and/or 90 mmHg or higher; Any clinical observation (clinical/physical evaluation) or laboratory finding that the investigator interprets as a risk to participation in the clinical trial or the presence of uncontrolled chronic disease(s); history of alcohol use disorder or illicit drug use in the past 2 years; Women of childbearing potential who are not using a reliable method of contraception or who are pregnant, breastfeeding, or planning to become pregnant; known allergy or hypersensitivity to the components of the medications used during the clinical trial; Known renal insufficiency, with an estimated GFR persistently below 30 mL/min/1.73 m²—as calculated by the CKD-EPI equation; Participation in clinical trial protocols within the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator deems that there may be a direct benefit to the participant. Known allergy or hypersensitivity to the components of the medications used during the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether the strategy of adding 180 mcg of menaeptenone to patients with cardiovascular risk factors who are already on medication can improve peripheral and central blood pressure parameters. Efficacy will be measured by the mean reduction in peripheral and central blood pressure (mmHg), improvement in arterial stiffness indices, and increased endothelial function as assessed by flow-mediated dilation, comparing data before the start of treatment and at the end of the study (ninety days more and less five days). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the strategy of adding 180 mcg of menaeptenone in patients with cardiovascular risk factors who are on medication, focusing on the following aspects: reduction in peripheral blood pressure (mmHg) over the course of the study, reduction in central blood pressure (mmHg) over the course of the study, changes in arterial stiffness, as measured by specific parameters (e.g., pulse wave velocity), and maintenance of endothelial function, assessed by flow-mediated dilation. Data will be collected and analyzed by comparing measurements taken at the initial visit and at the end of the study. | — |
Countries
BR
Contacts
Faculdade de Medicina da Universidade Federal de Goiás