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Clinical Trials/NL-OMON45212
NL-OMON45212
Completed
Not Applicable

Effects of aldosterone antagonism on microvascular function in obese individuals - Aldosterone antagonism and microvascular function

niversiteit Maastricht0 sites60 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
niversiteit Maastricht
Enrollment
60
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Age 40\-65 years
  • •\- Caucasian (because of ethnic differences in microvascular function, vascular stiffness, and the prevalence of cardiovascular disease and associated risk factors)
  • •\- Waist circumference \> 102 cm (men)/\> 88 cm (women)
  • •\- High\-normal blood pressure (office blood pressure: 130/85 \* 139/89 mm Hg) or stage I/II hypertension (office blood pressure: 140/90 mm Hg \* 179/109 mm Hg; 24h ABPM: 125/80 \* 169/99 mm Hg)

Exclusion Criteria

  • •\- Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
  • •\- Diabetes mellitus/impaired fasting glucose (fasting glucose values \> 6\.1 mmol/L), because not only diabetes, but also intermediate hyperglycaemia has been associated with microvascular disease, which impedes the distinction between cause and consequence of disturbances in glucose metabolism in the concerning individuals
  • •\- Grade 3 hypertension (office blood pressure: \> 180/110 mm Hg; ABPM \> 170/100 mm Hg) in order not to expose these individuals to unnecessary risks by interrupting or postponing antihypertensive treatment
  • •\- Unstable or severe pulmonary disease
  • •\- Unstable or severe thyroid disorders
  • •\- Inflammatory diseases
  • •\- Alcohol use \> 2 U/day (women)/\> 3 U/day (men)
  • •\- Use of glucose\-lowering medications, because of possible interference with microvascular function
  • •\- Use of corticosteroids (have also affinity for the mineralocorticoid receptor; can decrease the antihypertensive effect of Eplerenone), medication known to inhibit or induce CYP3A4 (possible interference with metabolism of Eplerenone), lithium (possible reduction of lithium excretion when used simultaneously with Eplerenone) , and tricyclic antidepressants or antipsychotic medication (risk of orthostatic hypotension when used simultaneously with Eplerenone), and regular use (weekly or several times a week) of NSAIDs (risk of acute renal dysfunction and disturbance of electrolyte excretion when used simultaneously with Eplerenone)
  • •\- Plasma potassium levels \< 3\.2 mmol/L or \> 5 mmol/L

Outcomes

Primary Outcomes

Not specified

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