Microvascular Function in Primary Aldosteronism

Essential Hypertension Clinical Trial

Official title:

Microvascular Function in Patients With Primary Aldosteronism and Essential Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02096939
• Other study ID #: 48364
• Status: Withdrawn
• Phase: N/A
• First received: March 24, 2014
• Last updated: August 24, 2015
• Start date: September 2014
• Est. completion date: April 2016

Study information

• Verified date: August 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

Patients with primary aldosteronism, which is the most prevalent form of secondary hypertension, have an increased rate of cardiovascular events, compared to patients with essential hypertension, even with equal severity of hypertension. This might be partially attributed to the association of increased aldosterone levels with insulin resistance. How this relation can be explained from a pathophysiological point of view, is insufficiently established.

Recently, microvascular dysfunction has been proposed as a link between insulin resistance and hypertension. Loss of NO-mediated vasodilation is an important feature of microvascular dysfunction; in addition, an impaired insulin-mediated microvascular NO production has been suggested to underlie the reduction in insulin-stimulated glucose disposal that is characteristic of insulin-resistant states. Increased aldosterone levels are not only associated with insulin resistance, but also with endothelial dysfunction. In addition, they interfere with the vascular effects of insulin.

Therefore, the investigators hypothesize that in patients with primary aldosteronism, increased aldosterone levels induce microvascular dysfunction through reduction of NO-availability, which contributes to the development of insulin resistance, and of hypertension, in addition to the sodium-retaining effects of aldosterone.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Patients with primary aldosteronism

• Age 18-70 years

• Confirmed diagnosis of primary aldosteronism

• Serum potassium > 3.5 mmol/L with or without supplementation

Patients with essential hypertension

• Age 18-70 years

• Secondary causes of hypertension excluded

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

• Unstable or severe pulmonary disease

• Inflammatory diseases

• Alcohol use > 2 U/day (women) / > 3 U/day (men)

• (Frequent) use of acetylsalicylic acid, NSAID's, dipyridamole and corticosteroids

• eGFR < 60 mL/min

• Impairment of hepatic function

• Pregnancy or lactation

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Essential Hypertension
• Hyperaldosteronism
• Hypertension
• Primary Aldosteronism

Intervention

Procedure:
• Adrenal extirpation

Drug:
• Antihypertensive medication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvascular recruitment in skeletal muscle during hyperinsulinaemia		Baseline	No
Primary	Microvascular recruitment in skeletal muscle during hyperinsulinaemia		3 months after (initiation of) treatment	No