Status:

RECRUITING

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

Lead Sponsor:

Hippocration General Hospital

Collaborating Sponsors:

National and Kapodistrian University of Athens

Conditions:

Primary Hypertension

Obesity

Eligibility:

All Genders

30-75 years

Phase:

NA

Brief Summary

Despite the available means of treating primary arterial hypertension, the prevalence of hypertensive patients with inadequately controlled blood pressure levels, remains high. The identification of b...

Detailed Description

Background : Hypertension remains the most prevalent modifiable risk factor associated with cardiovascular morbidity and mortality, however un-optimally treated hypertension prevalence remains alarmi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2025

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06208072

Start Date

September 1 2023

End Date

February 1 2025

Last Update

January 17 2024

Active Locations (1)

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Hypertension Unit, A' University Cardiology Clinic, Hippocration General Hospital of Athens

Athens, Greece, 115 27