Primary AldosteronismNCT02096939
Microvascular Function in Primary Aldosteronism
An observational study of Primary Aldosteronism and Essential Hypertension, run by Maastricht University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Aldosteronism, Essential Hypertension
- What is being tested?
- Adrenal extirpation and Antihypertensive medication
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twenty patients with primary aldosteronism and twenty patients with essential hypertension
Who may be able to join
- 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
Who cannot join
- 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
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- eGFR < 60 mL/min
- Impairment of hepatic function
- Pregnancy or lactation
About this study
Official title: Microvascular Function in Patients With Primary Aldosteronism and Essential Hypertension
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
- Being tested
- Adrenal extirpation, Antihypertensive medication
- Medical subject headings
- Hyperaldosteronism, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adrenal extirpationProcedure or surgery
Antihypertensive medicationDrug
| Study group | Role | What they receive |
|---|---|---|
| Primary aldosteronism | Patients with primary aldosteronism, who undergo surgery or will be started on antihypertensive medication, including mineralocorticoid receptor antagonists Receives: Procedure: Adrenal extirpation; Drug: Antihypertensive medication | |
| Essential hypertension | Patients with essential hypertension who will be started on antihypertensive medication Receives: Drug: Antihypertensive medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular recruitment in skeletal muscle during hyperinsulinaemia
Measured: Baseline
Microvascular recruitment in skeletal muscle during hyperinsulinaemia
Measured: 3 months after (initiation of) treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Schütten, Maastricht University Medical Center
- Investigators
- Prof. C.D.A. Stehouwer, MD, PhD, Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096939
- Sponsor's protocol ID
- 48364
- Status last verified
- Aug 2015
- First submitted
- 24 Mar 2014
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Function in Patients With Primary Aldosteronism and Essential Hypertension
- ClinicalTrials.gov ID
- NCT02096939
- Acronym / sponsor ID
- 48364
- Conditions
- Primary Aldosteronism, Essential Hypertension
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary aldosteronism | – | Procedure: Adrenal extirpation, Drug: Antihypertensive medicationPatients with primary aldosteronism, who undergo surgery or will be started on antihypertensive medication, including mineralocorticoid receptor antagonists |
| Essential hypertension | – | Drug: Antihypertensive medicationPatients with essential hypertension who will be started on antihypertensive medication |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty patients with primary aldosteronism and twenty patients with essential hypertension
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adrenal extirpation | Procedure or surgery | Primary aldosteronism |
| Antihypertensive medication | Drug | Essential hypertension, Primary aldosteronism |
Primary outcome
Microvascular recruitment in skeletal muscle during hyperinsulinaemia
Time frame: Baseline
Microvascular recruitment in skeletal muscle during hyperinsulinaemia
Time frame: 3 months after (initiation of) treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. C.D.A. Stehouwer, MD, PhD principal investigator
Maastricht University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism and Essential Hypertension, run by Maastricht University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular recruitment in skeletal muscle during hyperinsulinaemia (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.