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

NCT01728493 | Completed

• 1 other identifier: 40133.091.12
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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). Diagnosis of PA is relevant for two reasons:

1. 1.independent of the level of blood pressure, hypertension due to autonomous aldosterone secretion causes more cardiovascular damage than essential hypertension;
2. 2.PA requires specific treatment: adrenalectomy in case of APA and mineralocorticoid receptor antagonists (MRA) in case of BAH.
3. 3.International studies report a prevalence of PA in general practice of 6-13%. Prevalence in the Dutch population is still unknown;
4. 4.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;
5. 5.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.

Conditions

Primary Aldosteronism; Primary Hyperaldosteronism

Keywords

Prevalence; Primary aldosteronism; Organ damage; Mineralocorticoid receptor antagonists

Outcome Measures

Primary Outcomes (3)

• PAGODE part 1: prevalence

  Prevalence of primary aldosteronism in newly diagnosed hypertensive patients in Dutch general practice.

  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.

  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.

  4 months

Secondary Outcomes (2)

• PAGODE part 2: organ damage

  4 weeks

• PAGODE part 3: blood pressure regulation

  4 months

Other Outcomes (2)

• PAGODE part 2: organ damage

  4 weeks

• PAGODE part 3: blood pressure regulation

  4 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Part 1:
• Newly diagnosed hypertensive patients (according to the NHG-guideline 'Cardiovascular risk management');
• years or older;
• No use of antihypertensive medication.
• Part 2:
• Patients with increased aldosterone/renin ratio;
• 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;

You may not qualify if:

• Use of antihypertensive medication;
• Heart failure class II, III or IV (according to the New York Heart Association);
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr J Deinum

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 19, 2012
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

NL (1)