Primary HyperaldosteronismPHA-FMDNCT01978132
Primary Hyperaldosteronism and Ischemia-reperfusion Injury
A study testing forearm ischemia and reperfusion in people with Primary Hyperaldosteronism, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Patients with primary hyperaldosteronism experience more cardiovascular events compared to patients with primary hypertension, independent of the blood pressure level. In this research we hypothesize that patients with primary hyperaldosteronism are more susceptible to ischemia-reperfusion injury. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Hyperaldosteronism
- What is being tested?
- forearm ischemia and reperfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2013to 1 Jul 2017
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Primary hypertension
- Baseline aldosterone <0.30 nmol/l and aldosterone-renin-ratio<0.09
- Serum potassium ≥ 3.5 mmol/L
- Written informed consent
- Exclusion Criteria for both arms (patients with primary hyperaldosteronism and patients with primary hypertension:
Show all 15Show fewer
- Smoking
- History of atherosclerotic disease (myocardial infarction (MI), stroke, or peripheral vascular disease)
- Not possible to change the antihypertensive medication into only diltiazem with or without hydralazine, according to the treating physician.
- Not possible to temporarily interrupt statin treatment, if the patient use statins, according to the treating physician.
- Severe renal dysfunction (MDRD < 30 ml/min)
- Second/third degree AV-block on electrocardiography
- Cardiac failure
- Diabetes Mellitus
- Use of acetylsalicylic acid and NSAID's theophylline, and dipyridamole
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Centre
Nijmegen, Gelderland, 6525EZ
About this study
Official title: Primary Hyperaldosteronism and Endothelial Ischemia-reperfusion Injury
Patients with primary hyperaldosteronism experience more cardiovascular events compared to patients with primary hypertension, independent of the blood pressure level.
In this research we hypothesize that patients with primary hyperaldosteronism are more susceptible to ischemia-reperfusion injury.
Read the detailed description
Patients with PHA have an increased risk of cardiovascular events, independent of blood pressure level. Also in patients suffering a myocardial infarction, circulating aldosterone levels are associated with increased mortality. In animal models of myocardial infarction, the administration of exogenous aldosterone increased infarct size, although other studies did not report this effect. In similar models, antagonists of the mineralocorticoid receptor (MR) reduced infarct size, which was completely abolished in ecto-5'-nucleotidase (CD73, the enzyme that catalyses extracellular formation of the endogenous nucleoside adenosine) and adenosine receptor knock-out mice. Therefore, we hypothesize that patients with PHA have an increased susceptibility for ischemia-reperfusion (IR)-injury due to down-regulation of the enzyme CD73. We will use the reduction in brachial flow-mediated dilation (FMD) by forearm IR as a well-validated endpoint for (endothelial) IR-injury.
- Conditions
- Primary Hyperaldosteronism
- Being tested
- forearm ischemia and reperfusion
- Keywords
- primary hyperaldosteronism, primary hypertension, forearm ischemia-reperfusion, (reduction) in brachial artery FMD, endothelial ischemia-reperfusion injury
- 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.
forearm ischemia and reperfusionProcedure or surgery
both arms will be subjected to 20 minutes of forearm ischemia and 20 minutes of reperfusion.
| Study group | Role | What they receive |
|---|---|---|
| Primary hyperaldosteronism | Active comparator | patients with primary hyperaldosteronism will be subjected to the intervention forearm ischemia and reperfusion (20 minutes of forearm ischemia and 20 minutes of reperfusion).
Primary endpoint is the reduction in brachial FMD by forearm ischemia-reperfusion, as a measure of endothelial ischemia-reperfusion injury Receives: Procedure: forearm ischemia and reperfusion |
| Primary hypertension | Placebo comparator | Patients with primary hypertension (PHA excluded)will be subjected to 20 minutes of forearm ischemia and 20 minutes of reperfusion.
Primary endpoint is the reduction in brachial FMD by forearm ischemia-reperfusion, as a measure of endothelial ischemia-reperfusion injury Receives: Procedure: forearm ischemia and reperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
brachial FMD
primary outcome measure is the reduction in brachial artery FMD after 20 minutes of forearm ischemia and 20 minutes of reperfusion in patients with primary hyperaldosteronism (compared to patients with primary hypertension)
Measured: 1 day morning
Secondary outcomes (1)
CD73 and adenosine
Blood will be drawn to determine circulating adenosine concentration and the CD73 activity on mononuclear cells
Measured: one day morning (just before FMD experiment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startNov 2013
- Primary completion1 May 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperaldosteronismStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978132
- Sponsor's protocol ID
- NL45381.091.13
- Acronym
- PHA-FMD
- Status last verified
- Apr 2017
- First submitted
- 31 Oct 2013
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Hyperaldosteronism and Endothelial Ischemia-reperfusion Injury
- ClinicalTrials.gov ID
- NCT01978132
- Acronym / sponsor ID
- PHA-FMD / NL45381.091.13
- Conditions
- Primary Hyperaldosteronism
- Keywords
- primary hyperaldosteronism, primary hypertension, forearm ischemia-reperfusion, (reduction) in brachial artery FMD, endothelial ischemia-reperfusion injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 7 Nov 2013 (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 hyperaldosteronism experience more cardiovascular events compared to patients with primary hypertension, independent of the blood pressure level.
In this research we hypothesize that patients with primary hyperaldosteronism are more susceptible to ischemia-reperfusion injury.
Detailed description
Patients with PHA have an increased risk of cardiovascular events, independent of blood pressure level. Also in patients suffering a myocardial infarction, circulating aldosterone levels are associated with increased mortality. In animal models of myocardial infarction, the administration of exogenous aldosterone increased infarct size, although other studies did not report this effect. In similar models, antagonists of the mineralocorticoid receptor (MR) reduced infarct size, which was completely abolished in ecto-5'-nucleotidase (CD73, the enzyme that catalyses extracellular formation of the endogenous nucleoside adenosine) and adenosine receptor knock-out mice. Therefore, we hypothesize that patients with PHA have an increased susceptibility for ischemia-reperfusion (IR)-injury due to down-regulation of the enzyme CD73. We will use the reduction in brachial flow-mediated dilation (FMD) by forearm IR as a well-validated endpoint for (endothelial) IR-injury.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary hyperaldosteronism | Active comparator | Procedure: forearm ischemia and reperfusionpatients with primary hyperaldosteronism will be subjected to the intervention forearm ischemia and reperfusion (20 minutes of forearm ischemia and 20 minutes of reperfusion). Primary endpoint is the reduction in brachial FMD by forearm ischemia-reperfusion, as a measure of endothelial ischemia-reperfusion injury |
| Primary hypertension | Placebo comparator | Procedure: forearm ischemia and reperfusionPatients with primary hypertension (PHA excluded)will be subjected to 20 minutes of forearm ischemia and 20 minutes of reperfusion. Primary endpoint is the reduction in brachial FMD by forearm ischemia-reperfusion, as a measure of endothelial ischemia-reperfusion injury |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18-75 years
- Primary hypertension
- Baseline aldosterone <0.30 nmol/l and aldosterone-renin-ratio<0.09
- Serum potassium ≥ 3.5 mmol/L
- Written informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| forearm ischemia and reperfusionboth arms will be subjected to 20 minutes of forearm ischemia and 20 minutes of reperfusion. | Procedure or surgery | Primary hyperaldosteronism, Primary hypertension |
Primary outcome
brachial FMD
Time frame: 1 day morning
primary outcome measure is the reduction in brachial artery FMD after 20 minutes of forearm ischemia and 20 minutes of reperfusion in patients with primary hyperaldosteronism (compared to patients with primary hypertension)
1 secondary outcome
CD73 and adenosine
Time frame: one day morning (just before FMD experiment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing forearm ischemia and reperfusion in people with Primary Hyperaldosteronism, run by Radboud University Medical Center at 1 site in Netherlands.
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 15 inclusion and 0 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: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
brachial FMD (time frame: 1 day morning). 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 12 Oct 2017.