Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients

Prior treatment

• Participation in a clinical study involving an investigational drug or device within 4 weeks of screening
• Scheduled surgery or cardiovascular surgery over the next 6 months
• Absolute contra-indication to study drugs (eg. asthma) or previous intolerance of trial therapy
• 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
• 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

Other illness

• Secondary hypertension
• Recent (\<6 months) cardiovascular event requiring hospitalization (eg. myocardial infarction or stroke)
• Type 1 diabetes
• Addison's disease
• Hemodynamically significant valvular heart disease
• 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)
• 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

Lab values

• Chronic kidney disease assessed by Estimated Glomerular Filtration Rate (eGFR) \<45 mL/min
• Plasma potassium outside of normal range on two successive measurements during screening

Age

• Age \<30 or \>75

Other

• Inability to give informed consent
• Bilateral renal arteries stenosis
• Pregnancy, planning to conceive or women of childbearing potential, that is, not using effective contraception

• 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