Microvascular Function in Primary Aldosteronism

NCT02096939 | Withdrawn

• 1 other identifier: 48364
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Microvascular recruitment in skeletal muscle during hyperinsulinaemia

  Baseline

• Microvascular recruitment in skeletal muscle during hyperinsulinaemia

  3 months after (initiation of) treatment

Study Arms (2)

Primary aldosteronism

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

Procedure: Adrenal extirpation; Drug: Antihypertensive medication

Essential hypertension

Patients with essential hypertension who will be started on antihypertensive medication

Drug: Antihypertensive medication

Interventions

Adrenal extirpation PROCEDURE

Primary aldosteronism

Antihypertensive medication DRUG

Essential hypertension; Primary aldosteronism

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty patients with primary aldosteronism and twenty patients with essential hypertension

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

MeSH Terms

Conditions

Hyperaldosteronism; Essential Hypertension

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Prof. C.D.A. Stehouwer, MD, PhD

  Maastricht University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 25, 2015

Record last verified: 2015-08