Primary AldosteronismPAGODENCT01728493
Primary Aldosteronism in General Practice: Organ Damage, Epidemiology and Treatment
An observational study of Primary Aldosteronism and Primary Hyperaldosteronism, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Primary aldosteronism (PA) is the most frequent form of secondary hypertension. It is caused by autonomous secretion of aldosterone, encompassing a group of disorders which is for 99% predominated by unilateral aldosterone-producing adenoma (APA) and bilateral adrenal hyperplasia (BAH). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Aldosteronism, Primary Hyperaldosteronism
- How many people
- 700 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Newly diagnosed hypertensive patients in general practice (primary care).
Who may be able to join
- Part 1:
- Newly diagnosed hypertensive patients (according to the NHG-guideline 'Cardiovascular risk management');
- 18 years or older;
- No use of antihypertensive medication.
- Part 2:
- Patients with increased aldosterone/renin ratio;
Show all 17Show fewer
- Positive sodium loading test;
- Written informed consent.
- Part 2 + 3:
- Patients with normal aldosterone/renin ratio;
- Normal ARR;
- Written informed consent.
- Part 3:
- Patients with increased aldosterone/renin ratio;
- Positive sodium loading test;
- Normokalemic;
- Written informed consent.
Who cannot join
- Use of antihypertensive medication;
- Heart failure class II, III or IV (according to the New York Heart Association);
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6500 HB
About this study
Primary aldosteronism (PA) is the most frequent form of secondary hypertension. It is caused by autonomous secretion of aldosterone, encompassing a group of disorders which is for 99% predominated by unilateral aldosterone-producing adenoma (APA) and bilateral adrenal hyperplasia (BAH). Diagnosis of PA is relevant for two reasons:
- independent of the level of blood pressure, hypertension due to autonomous aldosterone secretion causes more cardiovascular damage than essential hypertension;
- PA requires specific treatment: adrenalectomy in case of APA and mineralocorticoid receptor antagonists (MRA) in case of BAH.
Read more
Although previously presumed a rare condition (prevalence <1%), PA is now estimated to affect 6 to 20% of the hypertensive population. Given this high prevalence of PA, as well as the amount of cardiovascular damage and the available specific treatment, the question is raised whether screening of PA should be introduced in Dutch general practice. To answer this important question, several issues with regard to PA need to be elucidated:
- International studies report a prevalence of PA in general practice of 6-13%. Prevalence in the Dutch population is still unknown;
- Because of underdiagnosis of PA and long delay in diagnosis of PA after recognition of hypertension (mean eight years), data on characteristics of early diagnosed PA are lacking. Proof of early cardiovascular damage would strengthen the case of screening for PA and needs to be studied;
- Consequently, the diagnostic delay has lead to lack of data on optimal treatment in early PA. In the current guideline (NHG-guideline 'Cardiovascular risk management') a regimen of antihypertensive drugs is advised, and only if hypertension is refractory for >6 months patients are referred. It is unknown if hypertension is resistant to therapy in the initial phase of PA. If not, this would also argue for early biochemical screening for PA, because even if blood pressure is controlled, the detrimental effect of aldosterone itself will go on unopposed. It is therefore required to study the response to antihypertensive drugs (not MRA) in these patients.
Read the detailed description
Rationale: Primary aldosteronism (PA) is the most frequent form of secondary hypertension. It is caused by autonomous secretion of aldosterone, encompassing a group of disorders which is for more than 99% predominated by unilateral aldosterone-producing adenoma (APA) and bilateral adrenal hyperplasia (BAH). Diagnosis of PA is relevant for two reasons: 1) independent of the level of blood pressure, hypertension due to autonomous aldosterone secretion causes more cardiovascular damage than essential hypertension; 2) PA requires specific treatment: adrenalectomy in case of APA and mineralocorticoid receptor antagonists (MRA) in case of BAH.
Although previously presumed a rare condition (prevalence <1%), PA is now estimated to affect 6 to 20% of the hypertensive population. Given this high prevalence of PA, as well as the amount of cardiovascular damage and the available specific treatment, the question has been raised whether screening of PA should be introduced in Dutch general practice. To answer this important question, several issues with regard to PA need to be elucidated:
- International studies report a prevalence of PA in general practice of 6-13%. Prevalence in the Dutch population is still unknown;
- Up to now, the laboratory test for screening for PA, the aldosterone/renin ratio (ARR), is primarily used in secondary care. The relation between the ARR and outcomes in primary care is unknown;
- Because of underdiagnosis of PA and long delay in diagnosis of PA after recognition of hypertension (mean eight years), data on characteristics of early diagnosed PA are lacking. Indications of early cardiovascular damage would strengthen the case of screening for PA and needs to be studied.
- Conditions
- Primary Aldosteronism, Primary Hyperaldosteronism
- Keywords
- Prevalence, Primary aldosteronism, Organ damage, Mineralocorticoid receptor antagonists
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | - newly diagnosed hypertensive patients in general practice | |
| Part 2: | * newly diagnosed hypertensive patients with primary aldosteronism * newly diagnosed hypertensive patients with essential hypertension | |
| Part 3: | * newly diagnosed hypertensive patients with normokalemic primary aldosteronism * newly diagnosed hypertensive patients with essential hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAGODE part 1: prevalence
Prevalence of primary aldosteronism in newly diagnosed hypertensive patients in Dutch general practice.
Measured: 4 months
PAGODE part 2: organ damage
Difference in cardiorenovascular damage in patients with versus without primary aldosteronism, based on a composite of the following parameters:
- Left ventricular mass index in g/m2;
- Intima-media thickness of carotid artery in mm;
- Pulse wave velocity in m/s;
- Central aortic blood pressure in mmHg;
- Flow-mediated dilation in %;
- Albuminuria in mg albumin per mmol creatinin.
Measured: 4 weeks
PAGODE part 3: blood pressure regulation
Difference in reduction of daytime systolic ambulatory blood pressure measurement (ABPM) in patients with normokalemic primary aldosteronism versus patients with essential hypertension in a standardized treatment regimen during conventional antihypertensive therapy.
Measured: 4 months
Secondary outcomes (2)
PAGODE part 2: organ damage
To observe differences between newly diagnosed hypertensive patients with versus without primary aldosteronism in:
- Serum potassium;
- Low density lipoprotein;
- Total cholesterol to high density lipoprotein ratio.
Measured: 4 weeks
PAGODE part 3: blood pressure regulation
To observe differences between newly diagnosed hypertensive patients with versus without primary aldosteronism in:
- Reduction of daytime systolic ABPM in patients with primary aldosteronism versus patients with essential hypertension in a standardized treatment regimen during spironolactone (or eplerenone);
- Serum potassium response using conventional antihypertensive medication;
- Adverse effects using conventional antihypertensive medication;
- Serum potassium response using spironolactone (or eplerenone);
- Adverse effects using spironolactone (or eplerenone).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2012 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionFeb 2016
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JDeinum, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728493
- Sponsor's protocol ID
- 40133.091.12
- Acronym
- PAGODE
- Status last verified
- Apr 2016
- First submitted
- 13 Nov 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Aldosteronism in General Practice: Organ Damage, Epidemiology and Treatment
- ClinicalTrials.gov ID
- NCT01728493
- Acronym / sponsor ID
- PAGODE / 40133.091.12
- Conditions
- Primary Aldosteronism, Primary Hyperaldosteronism
- Keywords
- Prevalence, Primary aldosteronism, Organ damage, Mineralocorticoid receptor antagonists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Nov 2012 (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.
Primary aldosteronism (PA) is the most frequent form of secondary hypertension. It is caused by autonomous secretion of aldosterone, encompassing a group of disorders which is for 99% predominated by unilateral aldosterone-producing adenoma (APA) and bilateral adrenal hyperplasia (BAH). Diagnosis of PA is relevant for two reasons:
- independent of the level of blood pressure, hypertension due to autonomous aldosterone secretion causes more cardiovascular damage than essential hypertension;
- PA requires specific treatment: adrenalectomy in case of APA and mineralocorticoid receptor antagonists (MRA) in case of BAH.
Although previously presumed a rare condition (prevalence <1%), PA is now estimated to affect 6 to 20% of the hypertensive population. Given this high prevalence of PA, as well as the amount of cardiovascular damage and the available specific treatment, the question is raised whether screening of PA should be introduced in Dutch general practice. To answer this important question, several issues with regard to PA need to be elucidated:
- International studies report a prevalence of PA in general practice of 6-13%. Prevalence in the Dutch population is still unknown;
- Because of underdiagnosis of PA and long delay in diagnosis of PA after recognition of hypertension (mean eight years), data on characteristics of early diagnosed PA are lacking. Proof of early cardiovascular damage would strengthen the case of screening for PA and needs to be studied;
- Consequently, the diagnostic delay has lead to lack of data on optimal treatment in early PA. In the current guideline (NHG-guideline 'Cardiovascular risk management') a regimen of antihypertensive drugs is advised, and only if hypertension is refractory for >6 months patients are referred. It is unknown if hypertension is resistant to therapy in the initial phase of PA. If not, this would also argue for early biochemical screening for PA, because even if blood pressure is controlled, the detrimental effect of aldosterone itself will go on unopposed. It is therefore required to study the response to antihypertensive drugs (not MRA) in these patients.
Detailed description
Rationale: Primary aldosteronism (PA) is the most frequent form of secondary hypertension. It is caused by autonomous secretion of aldosterone, encompassing a group of disorders which is for more than 99% predominated by unilateral aldosterone-producing adenoma (APA) and bilateral adrenal hyperplasia (BAH). Diagnosis of PA is relevant for two reasons: 1) independent of the level of blood pressure, hypertension due to autonomous aldosterone secretion causes more cardiovascular damage than essential hypertension; 2) PA requires specific treatment: adrenalectomy in case of APA and mineralocorticoid receptor antagonists (MRA) in case of BAH.
Although previously presumed a rare condition (prevalence <1%), PA is now estimated to affect 6 to 20% of the hypertensive population. Given this high prevalence of PA, as well as the amount of cardiovascular damage and the available specific treatment, the question has been raised whether screening of PA should be introduced in Dutch general practice. To answer this important question, several issues with regard to PA need to be elucidated:
- International studies report a prevalence of PA in general practice of 6-13%. Prevalence in the Dutch population is still unknown;
- Up to now, the laboratory test for screening for PA, the aldosterone/renin ratio (ARR), is primarily used in secondary care. The relation between the ARR and outcomes in primary care is unknown;
- Because of underdiagnosis of PA and long delay in diagnosis of PA after recognition of hypertension (mean eight years), data on characteristics of early diagnosed PA are lacking. Indications of early cardiovascular damage would strengthen the case of screening for PA and needs to be studied.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | – | –- newly diagnosed hypertensive patients in general practice |
| Part 2: | – | –* newly diagnosed hypertensive patients with primary aldosteronism * newly diagnosed hypertensive patients with essential hypertension |
| Part 3: | – | –* newly diagnosed hypertensive patients with normokalemic primary aldosteronism * newly diagnosed hypertensive patients with essential hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed hypertensive patients in general practice (primary care).
Key inclusion criteria (17 listed)
- Newly diagnosed hypertensive patients (according to the NHG-guideline 'Cardiovascular risk management');
- 18 years or older;
- No use of antihypertensive medication.
- Patients with increased aldosterone/renin ratio;
- Positive sodium loading test;
Key exclusion criteria (3 listed)
- Use of antihypertensive medication;
- Heart failure class II, III or IV (according to the New York Heart Association);
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PAGODE part 1: prevalence
Time frame: 4 months
Prevalence of primary aldosteronism in newly diagnosed hypertensive patients in Dutch general practice.
PAGODE part 2: organ damage
Time frame: 4 weeks
Difference in cardiorenovascular damage in patients with versus without primary aldosteronism, based on a composite of the following parameters: 1. Left ventricular mass index in g/m2; 2. Intima-media thickness of carotid artery in mm; 3. Pulse wave velocity in m/s; 4. Central aortic blood pressure in mmHg; 5. Flow-mediated dilation in %; 6. Albuminuria in mg albumin per mmol creatinin.
PAGODE part 3: blood pressure regulation
Time frame: 4 months
Difference in reduction of daytime systolic ambulatory blood pressure measurement (ABPM) in patients with normokalemic primary aldosteronism versus patients with essential hypertension in a standardized treatment regimen during conventional antihypertensive therapy.
2 secondary outcomes
PAGODE part 2: organ damage
Time frame: 4 weeks
PAGODE part 3: blood pressure regulation
Time frame: 4 months
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 6 Apr 2016.
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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?
An observational study of Primary Aldosteronism and 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 17 inclusion and 3 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 6 Apr 2016. 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. 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?
PAGODE part 1: prevalence (time frame: 4 months). The study lists 3 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 6 Apr 2016.