Microvascular Function in Primary Aldosteronism

NCT ID: NCT02096939

Last Updated: 2015-08-25

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-04-30

Brief 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.

Conditions

Primary Aldosteronism; Essential Hypertension

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Primary aldosteronism

Patients with primary aldosteronism, who undergo surgery or will be started on antihypertensive medication, including mineralocorticoid receptor antagonists

Adrenal extirpation

Intervention Type: PROCEDURE

Antihypertensive medication

Intervention Type: DRUG

Essential hypertension

Patients with essential hypertension who will be started on antihypertensive medication

Antihypertensive medication

Intervention Type: DRUG

Interventions

Adrenal extirpation

Intervention Type: PROCEDURE

Antihypertensive medication

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Monica Schütten

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. C.D.A. Stehouwer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Hospital

Other Identifiers

48364

Identifier Type: -

Identifier Source: org_study_id