Outcome of Patients With Primary Aldosteronism

Study Overview
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Brief Summary
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Majority of patients with hypertension have primary hypertension (without an underlying cause). Primary aldosteronism (PA) is the most common cause of secondary hypertension, and can be found in 5-10% of patients locally. PA is caused by excessive release of a hormone (aldosterone) from the adrenal glands, which can be unilateral (one gland) or bilateral (both glands). It has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, leading to increased cardiovascular morbidity and mortality. This is supported by studies showing reversal of these effects after treatment for PA. The investigators aim to assess the long-term cardiovascular, and renal outcomes of patients with PA, compared to patients with essential hypertension.

Official Title
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Long-term Outcomes in Patients With Primary Aldosteronism After Treatment

Conditions
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Cardiovascular Morbidity, Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral), Adrenalectomy; Status, Mineralocorticoid Excess, Mineralocorticoid Antagonists [Aldosterone Antagonists] Causing Adverse Effects in Therapeutic Use, Chronic Renal Disease, Hypokalemia

Intervention / Treatment
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* Procedure: Unilateral adrenalectomy in patients with unilateral disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with suspected primary aldosteronism Exclusion Criteria: Nil

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery<br>Patients treated with surgery | Procedure: Unilateral adrenalectomy in patients with unilateral disease<br>* Unilateral adrenalectomy in patients with unilateral disease<br>|
| Medications<br>Patients treated with mineralocorticoid antagonists or potassium sparing diuretics for primary aldosteronism | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in systolic blood pressure before and after treatment | change in systolic blood pressure | six months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in diastolic blood pressure before and after treatment | change in diastolic blood pressure | six months after treatment | 
| change in systolic blood pressure before and after treatment | change in systolic blood pressure | through study completion, an average of 5 years | 
| change in diastolic blood pressure before and after treatment | change in diastolic blood pressure | through study completion, an average of 5 years | 
| cardiovascular outcome | incidence of new cardiovascular events including acute myocardial infarction, revascularisation percutaneously, coronary artery bypass graft, stroke, admission for congestive cardiac failure, atrial fibrillation | through study completion, an average of 5 years | 
| chronic kidney disease | incidence of worsening chronic kidney disease, decline of glomerular filtration rate by 15ml/min from at least 60m/min | through study completion, an average of 5 years | 
| Renal Progression | rate of decline of glomerular filtration rate | through study completion, an average of 5 years | 
| variables that predict unilateral disease | Identify variables that are more common in patients with unilateral disease | through study completion, an average of 5 years | 
| variables that predict blood pressure response | Identify variables that are more common in patients with positive blood pressure response | through study completion, an average of 5 years |