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Primary Aldosteronism in General Practice: Organ Damage, Epidemiology and Treatment (PAGODE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Radboud University
Sponsor:
Information provided by (Responsible Party):
JDeinum, Radboud University
ClinicalTrials.gov Identifier:
NCT01728493
First received: November 13, 2012
Last updated: July 23, 2013
Last verified: May 2013
  Purpose

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:

  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.

Condition
Primary Aldosteronism
Primary Hyperaldosteronism

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Primary Aldosteronism in General Practice: Organ Damage, Epidemiology and Treatment

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • PAGODE part 1: prevalence [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Prevalence of primary aldosteronism in newly diagnosed hypertensive patients in Dutch general practice.

  • PAGODE part 2: organ damage [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • PAGODE part 2: organ damage [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    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.

  • PAGODE part 3: blood pressure regulation [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    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).


Other Outcome Measures:
  • PAGODE part 2: organ damage [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    To observe differences between newly diagnosed hypertensive patients with versus without primary aldosteronism in:

    1. Serum sodium;
    2. Serum glucose;
    3. Diastolic blood pressure.

  • PAGODE part 3: blood pressure regulation [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    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.


Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 1100
Study Start Date: September 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Part 1: newly diagnosed hypertensive patients
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Newly diagnosed hypertensive patients in general practice (primary care).

Criteria

Inclusion Criteria:

Part 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 Criteria:

  1. Use of antihypertensive medication;
  2. Heart failure class II, III or IV (according to the New York Heart Association);
  3. Pregnancy or breastfeeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: JDeinum, Dr J Deinum, Radboud University
ClinicalTrials.gov Identifier: NCT01728493     History of Changes
Other Study ID Numbers: 40133.091.12
Study First Received: November 13, 2012
Last Updated: July 23, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Prevalence
Primary aldosteronism
Organ damage
Mineralocorticoid receptor antagonists

Additional relevant MeSH terms:
Hyperaldosteronism
Adrenal Gland Diseases
Adrenocortical Hyperfunction
Endocrine System Diseases
Mineralocorticoid Receptor Antagonists
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014