The Predictive Role of Urinary Proteomics in Blood Pressure Response of Obese Hypertensive Treated With Irbesartan or Eplerenone.

Launched by HIPPOCRATION GENERAL HOSPITAL · Jan 5, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how certain proteins found in urine can help predict how well obese patients with high blood pressure will respond to treatments with two medications: irbesartan or eplerenone. High blood pressure, also known as hypertension, is a common condition that can be challenging to manage, especially in obese patients. The researchers hope that by identifying specific proteins in urine, they can better tailor treatments and improve blood pressure control for these patients.

To participate in the study, individuals must be obese (with a body mass index between 30 and 39.99) and have specific blood pressure readings indicating high blood pressure. Participants will be required to sign a consent form to join the study. Throughout the trial, they will undergo tests to monitor their blood pressure and provide urine samples for analysis. It's important to note that certain health conditions, such as heart disease or kidney problems, may prevent someone from participating. Overall, this study aims to improve our understanding of blood pressure treatment in obese patients and help develop more effective management strategies.

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Eligibility criteria

• Inclusion Criteria:
• • Systolic office blood pressure 140-179mmHg and/or diastolic office blood pressure 90-119mmHg
• • Mean systolic 24h ABPM \>130mmHg and/or mean diastolic ABPM \>80mmHg
• • Obese patient with BMI 30-39.99kg/m2
• • Signed informed consent
• Exclusion Criteria:
• • Participation in an Investigational Medicinal Product (IMP) or invasive device clinical trial during the study or in the last 6 months
• • Patient with secondary arterial hypertension
• • Patient with a history within 6 months of: Myocardial infarction, Unstable angina, Stroke
• • Patient with type 1 diabetes
• • Patient with systolic heart failure EF≤40%
• • Patient with chronic kidney disease (eGFR\<45mL/min/1.73m2)
• • Patient with bilateral renal artery stenosis
• • Patient with hyperkalemia (\>5.5 mEq/L)
• • Patient with hemodynamically significant valvular heart disease
• • Patient with Addison's disease
• • Female patient in pregnancy or caesarean section or female patient planning pregnancy.
• • Planned surgery or cardiovascular surgery in the next 6 months
• • Patient with absolute contraindication to any EDPS
• • Patient who needs to receive study medication for a different reason
• • Patient with neoplasia undergoing treatment (radiotherapy, chemotherapy, immunotherapy)
• • Patient with synchronous systemic disease with a survival expectancy less than the end of the study
• • Any condition that, in the judgment of the investigator, may adversely affect the efficacy and/or safety of the Investigational Medicinal Products (IEDs) (alcohol abuse, drug use, mental retardation)
• • Patient who has received treatment with systemic corticosteroids at least 3 months before joining the study
• • Patient receiving α-blockers with the exception of alfuzosin and tamsulosin for prostatic symptoms