Status:
COMPLETED
Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients
Lead Sponsor:
Hippocration General Hospital
Conditions:
Hypertension
Obesity
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief Summary
Obesity is a complex metabolic state at which many pathophysiological pathways seem to interfere, like imbalance of autonomic nervous system, as well as renin-angiotensin-aldosterone system (RAAS) act...
Detailed Description
The present study plans to enroll obese patients (BMI= 30-40 kg/m2) of 30-75 years of age, with untreated or never-treated essential hypertension to either eplerenone-based or irbesartan-based therapy...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 30-75 years of age
- Written consent
- Untreated or never-treated arterial hypertension with office systolic blood pressure of 140-180 mmHg and/or diastolic blood pressure of 90-120 mmHg, confirmed by 24-hour ambulatory blood pressure measurements of mean ambulatory systolic blood pressure over 130 mmHg and/or mean ambulatory diastolic blood pressure over 80 mmHg
- Obesity, confirmed estimated by Body Mass Index (BMI) of 30-40 kg/m2
- Exclusion Criteria
- Age \<30 or \>75
- Inability to give informed consent
- Participation in a clinical study involving an investigational drug or device within 4 weeks of screening
- Secondary hypertension
- Recent (\<6 months) cardiovascular event requiring hospitalization (eg. myocardial infarction or stroke)
- Type 1 diabetes
- Chronic kidney disease assessed by Estimated Glomerular Filtration Rate (eGFR) \<45 mL/min
- Bilateral renal arteries stenosis
- Addison's disease
- Hemodynamically significant valvular heart disease
- Plasma potassium outside of normal range on two successive measurements during screening
- Pregnancy, planning to conceive or women of childbearing potential, that is, not using effective contraception
- Scheduled surgery or cardiovascular surgery over the next 6 months
- Absolute contra-indication to study drugs (eg. asthma) or previous intolerance of trial therapy
- History of sustained atrial fibrillation
- Requirement for study drug for reason other than to treat hypertension, (eg, β-blockers for angina or aldosterone antagonists for heart failure)
- Neoplasm under treatment (radiotherapy / chemotherapy / immunotherapy)
- Any concomitant condition that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the study drug or
- severely limit that patients' life-span or ability to complete the study (eg, alcohol or drug abuse, disabling or terminal illness, mental
- disorders)
- Contemporary systemic disease with life expectancy shorter than the end of the study
- Treatment with any of the following medications:
- Oral corticosteroids within 3 months of screening. Treatment with systemic corticosteroids is also prohibited during study participation
- Chronic stable use, or unstable use of NSAIDs (other than low dose aspirin) is prohibited. Chronic use is defined as \>3 consecutive or non-consecutive days of treatment per week. In addition, intermittent use of NSAIDs is strongly discouraged throughout the study and NSAIDs if required, must not be used for more than a total of 2 days. For those requiring analgesics during the study, paracetamol is recommended.
- The use of short-acting nitrates (eg, sublingual nitroglycerin) is permitted.
- The use of sympathomimetic decongestants is permitted, however, not within 1 day prior to any study visit/BP assessment
- The use of theophylline is permitted but the dose must be stable for at least 4 weeks prior to screening and throughout the study;
- The use of phosphodiesterase type V inhibitors is permitted; however, study participants must refrain from taking these medications for at least 1 day prior to screening or any subsequent study visits
- The use of α-blockers is not permitted, with the exception of alfuzosin and tamsulosin for prostatic symptoms
Exclusion
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT03476616
Start Date
September 1 2018
End Date
June 30 2025
Last Update
July 31 2025
Active Locations (1)
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1
Hypertension Unit, First Cardiology Clinic, Hippocration General Hospital, University of Athens, Athens, Greece
Athens, Athens, Greece, 11527