An observational study in Primary Aldosteronism and Primary Hyperaldosteronism, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-06.
Sponsored by Radboud University Medical Center · Observational
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:
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:
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:
193 studies on the registry are indexed under Hyperaldosteronism; 89 are open to participants now.
This study's enrollment of 700 is above the median of 200 across 98 observational studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Newly diagnosed hypertensive patients in general practice (primary care).
Part 1:
Part 2:
Part 2 + 3:
Part 3:
Exclusion Criteria:
- newly diagnosed hypertensive patients in general practice
* newly diagnosed hypertensive patients with primary aldosteronism * newly diagnosed hypertensive patients with essential hypertension
* newly diagnosed hypertensive patients with normokalemic primary aldosteronism * newly diagnosed hypertensive patients with essential hypertension
PAGODE part 1: prevalence
Prevalence of primary aldosteronism in newly diagnosed hypertensive patients in Dutch general practice.
Time frame: 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: 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.
Time frame: 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.
Time frame: 4 months
PAGODE part 2: organ damage
To observe differences between newly diagnosed hypertensive patients with versus without primary aldosteronism in: 1. Serum potassium; 2. Low density lipoprotein; 3. Total cholesterol to high density lipoprotein ratio.
Time frame: 4 weeks
PAGODE part 3: blood pressure regulation
To observe differences between newly diagnosed hypertensive patients with versus without primary aldosteronism in: 1. Reduction of daytime systolic ABPM in patients with primary aldosteronism versus patients with essential hypertension in a standardized treatment regimen during spironolactone (or eplerenone); 2. Serum potassium response using conventional antihypertensive medication; 3. Adverse effects using conventional antihypertensive medication; 4. Serum potassium response using spironolactone (or eplerenone); 5. Adverse effects using spironolactone (or eplerenone).
Time frame: 4 months
PAGODE part 2: organ damage
To observe differences between newly diagnosed hypertensive patients with versus without primary aldosteronism in: 1. Serum sodium; 2. Serum glucose; 3. Diastolic blood pressure.
Time frame: 4 weeks
PAGODE part 3: blood pressure regulation
To observe differences between newly diagnosed hypertensive patients with versus without primary aldosteronism in: 1. Reduction in 24 hour ABPM using conventional antihypertensive medication; 2. Reduction in 24 hour ABPM using mineralocorticoid receptor antagonists.
Time frame: 4 months
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Radboud University Medical Center