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Primary aldosteronism in general practice: Organ damage, epidemiology and treatment.


- candidate number13227
- NTR NumberNTR3578
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-aug-2012
- Secondary IDsNL40133.091.12 Regional independent medical ethical committee Nijmegen-Arnhem
- Public TitlePrimary aldosteronism in general practice: Organ damage, epidemiology and treatment.
- Scientific TitlePrimary aldosteronism in general practice: Organ damage, epidemiology and treatment.
- ACRONYMPAGODE
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPrevalence, Primary aldosteronism, Organ damage, Mineralocorticoid receptor antagonists
- Inclusion criteriaPart 1:
1. Newly diagnosed hypertensive patients (according to the NHG-guideline 'Cardiovascular risk management');
2. 18 years or older;
3. No use of antihypertensive medication.

Part 2:
1. Patients with increased aldosterone/renin ratio;
2. Positive sodium loading test;
3. Written informed consent.

Part 2 + 3:
1. Patients with normal aldosterone/renin ratio;
2. Normal ARR;
3. Written informed consent.

Part 3:
1. Patients with increased aldosterone/renin ratio;
2. Positive sodium loading test;
3. Normokalemic;
4. Written informed consent.
- Exclusion criteria1. Use of antihypertensive medication;
2. Heart failure class II, III or IV (according to the New York Heart Association);
3. Pregnancy or breastfeeding.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 15-mrt-2013
- planned closingdate31-dec-2015
- Target number of participants1100
- InterventionsStudy design:

Part 1:
Prospective cross-sectional study. Every newly diagnosed hypertensive patient in general practice will participate in screening for PA.

Part 2:
Descriptive cross-sectional study in which cardiovascular parameters and risk factors in newly diagnosed hypertensive patients with confirmed PA (confirmation by a positive sodium loading test) will be compared with newly diagnosed hypertensive patients without PA.

Part 3:
Clinical observational study in which patients with confirmed normokalemic PA and matched controls with essential hypertension will receive conventional antihypertensive medication by a standardized treatment regimen in addition to lifestyle counselling. After a wash-out period, therapy with mineralocorticoid receptor antagonists will follow.

In part 3 of our study newly diagnosed hypertensive patients with and without PA will receive the same sequence of pharmacological antihypertensive treatment for four months in addition to lifestyle counselling. Week 1-8 will be therapy according to the guidelines, week 9-12 will be a wash-out period, week 13-16 will be PA-specific therapy (MRA).
1. Week 1-4: amlodipine 5 mg once daily;
2. Week 5-8: continue amlodipine 5 mg once daily, in case of insufficient reduction of blood pressure lisinopril 10 mg once daily will be added;
3. Week 9-12: stop amlodipine and lisinopril (wash-out period);
4. Week 13-16: spironolactone 25 mg once daily.
- Primary outcomePart 1: Prevalence of PA in newly diagnosed hypertensive patients in Dutch general practice;

Part 2: Difference in cardiorenovascular damage in patients with versus without PA, 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.

Part 3: Difference in reduction of daytime systolic ABPM in patients with normokalemic PA versus patients with essential hypertension in a standardized treatment regimen during conventional antihypertensive therapy.
- Secondary outcomePart 2: To observe differences in:
1. Serum potassium;
2. Low density lipoprotein;
3. Total cholesterol to high density lipoprotein ratio.

Part 3: To observe differences in:
1. Reduction of daytime systolic ABPM in patients with PA 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).
- TimepointsPart 1:
1100 patients with newly diagnosed hypertensia will be included in 2 years time.

Part 2:
1 timepoint for the 5 cardiorenovascular measurements.

Part 3:
Measurements according to the standards (lab 10-14 days after ACE-I or spironolacton, bloodpressure every 4 weeks).
- Trial web sitewww.pagodestudy.com
- statusplanned
- CONTACT FOR PUBLIC QUERIES S.C. Käyser
- CONTACT for SCIENTIFIC QUERIES S.C. Käyser
- Sponsor/Initiator Radboud University Medical Centre Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- PublicationsN/A
- Brief summaryPrimary 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: 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 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:
1) International studies report a prevalence of PA in general practice of 6-13%. Prevalence in the Dutch population is still unknown;
2) 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;
3) 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.
- Main changes (audit trail)Inclusion starts 1-9-2013
- RECORD12-aug-2012 - 24-mei-2013


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