Microvascular Function in Primary Aldosteronism

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02096939
Collaborator
(none)
0
19

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Adrenal extirpation
  • Drug: Antihypertensive medication

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Microvascular Function in Patients With Primary Aldosteronism and Essential Hypertension
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Apr 1, 2016
Anticipated Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Microvascular recruitment in skeletal muscle during hyperinsulinaemia [Baseline]

  2. Microvascular recruitment in skeletal muscle during hyperinsulinaemia [3 months after (initiation of) treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Maastricht University Medical Center

Investigators

  • Principal Investigator: Prof. C.D.A. Stehouwer, MD, PhD, Maastricht University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Monica Schütten, MD, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT02096939
Other Study ID Numbers:
  • 48364
First Posted:
Mar 26, 2014
Last Update Posted:
Aug 25, 2015
Last Verified:
Aug 1, 2015

Study Results

No Results Posted as of Aug 25, 2015