Prospective and open label study with blind end point evaluation on the effect of mineralcorticoid receptor inhibition on endothelial function of the micro- and macrovasculature in patient with metabolic syndrome

Phase 1

• Conditions: Metabolic syndrome; MedDRA version: 12.1Level: LLTClassification code 10052066Term: Metabolic syndrome

• Registration Number: EUCTR2010-018639-17-DE
• Lead Sponsor: niversity Hospital Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-25
• Study Completion: 2012-08-31
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

•Male patients aged > 18 years
•with mild uncomplicated primary arterial hypertension with a mean sitting SPB = 130 mmHg or DBP = 85 mmHg or treated hypertension and
•at least 2 of the following traits of the metabolic syndrome (ATP III criteria):
•abdominal obesity (abdominal girth = 88 cm in females and = 102 cm in males),
•triglyceride level = 150 mg/dL or treatment for elevated triglyzerides,
•HDL < 40 mg/dL for men and < 50 mg/dL for women or treatment for low HDL
•fasting blood glucose = 100 mg/dL and = 126 mg/dl.

•Written informed consent
•Agreement to attend all study visits as planned in the protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

••Patients with or without antihypertensive therapy and average blood pressure > 160/100 mmHg
•Patients with secondary hypertension
•Patients with one antihypertensive agent maximally dosed or two (or less) agents with half (or less) of maximum approved dose
•Patients with diabetes mellitus type 1 or type 2
•Smokers and ex-smokers < 1 year
•Female patients (to prevent effects of changes in endothelial function attributable to the menstrual cycle)
•Patients with sick sinus syndrome
•Patients with higher degree of sinoatrial or atrioventricular block (II-III?)
•Patients with bradycardia (< 50 beats/min)
•Patients with malignant arrhythmias
•Patients with known cardiovascular, disease
•Patients with known cerebrovacular disease
•Patients with peripheral occlusive artery disease
•Patients with history of epilepsy
•Patients with severe hepatic disease (serum GOT, GPT, ?-GT, AP, bilirubin > 300 of uppper normal range)
•Patients with renal disease defined by eGFR < 60 ml/min/1,73m2
•Patients with history of malignant disease within the last 2 years
•Patients with history of depression
•Patients with drug or alcohol abuse
•Use of any investigational drug within 28 days before study entry
•Known allergy or a known intolerance to the study drug
•Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol, especially likelihood of the need for additional antihypertensive medication
•Serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases
•Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
•Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
•Subject unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of eplerenone on endothelial function of retinal arterioles in patients with metabolic function;Secondary Objective: To investigate the effect of eplerenone in metabolic syndrome on<br>- flow mediated dilation of the brachial artery<br>- distensibility of the carotid artery<br>- parameters of lipid and glucose metabolism<br>- steroid hormones (aldosterone, cortisone, cortisol) in serum and urine;Primary end point(s): Change of basal nitric oxide activity (as assessed by change of retinal capillary flow in response to nitric oxide inhibition) after ten weeks of treatment with eplerenone.