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Microvascular Function in Primary Aldosteronism

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ClinicalTrials.gov Identifier: NCT02096939
Recruitment Status : Withdrawn
First Posted : March 26, 2014
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Monica Schütten, Maastricht University Medical Center

Study Description
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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
Primary Aldosteronism Essential Hypertension Procedure: Adrenal extirpation Drug: Antihypertensive medication

Study Design
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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 : September 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Microvascular recruitment in skeletal muscle during hyperinsulinaemia [ Time Frame: Baseline ]
  2. Microvascular recruitment in skeletal muscle during hyperinsulinaemia [ Time Frame: 3 months after (initiation of) treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Twenty patients with primary aldosteronism and twenty patients with essential hypertension
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096939


Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Prof. C.D.A. Stehouwer, MD, PhD Maastricht University Hospital
More Information
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Responsible Party: Monica Schütten, MD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02096939    
Other Study ID Numbers: 48364
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Hyperaldosteronism
Vascular Diseases
Cardiovascular Diseases
 Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Antihypertensive Agents