Prospective Study Assessing Blood Pressure and Other Outcomes Post-treatment in 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). Secondary hypertension (due to an underlying disease) is important to recognize, as treatment can lead to cure of hypertension. 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). Distinction between two is crucial as unilateral disease is treated with the aim of cure by surgery, and bilateral disease is treated by medication. It has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, diabetes and quality of life. This is supported by studies showing reversal of these effects after treatment for PA. In addition, improvements after surgery appears to be superior to medical treatment, although studies have found variable results. Hence, the investigators aim to accurately subtype patients with PA into unilateral or bilateral disease and study the post-treatment response after both surgery and medicine with regards to the effects on blood pressure, cardiovascular, renal, metabolic and quality of life.

Official Title
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Prospective Study Assessing Blood Pressure, Cardiovascular, Endothelial and Other Outcomes poSt-surgical and Medical Treatment in Patients With Primary Aldosteronism

Conditions
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Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Intervention / Treatment
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* Procedure: Adrenalectomy
* Drug: Mineralocorticoid Receptor Antagonists


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i. Legally capacitated ii. 21-80 years iii. Diagnosed with primary aldosteronism iv. Patient is willing, or has undergone, adrenal surgery (in case of unilateral disease), or medical treatment (if not keen for surgery, medically unfit, or has bilateral disease) Exclusion Criteria: i. Unable to give consent ii. < 21 years or > 80 years iii. Glucocorticoid remediable aldosteronism iv. Adrenal Carcinoma v. Severe or terminal medical condition(s) that in the view of the investigator prohibits participation in the study or interferes with possible treatment or health-related quality of life, e.g. cancer, end-stage liver disease, end stage renal failure vi. Female patients who are pregnant, intending to become pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medical Treatment<br>Patients who undergo medical treatment, in view of bilateral PA, or unilateral PA not keen for surgery, or indeterminate (lack of localisation on tests) | Drug: Mineralocorticoid Receptor Antagonists<br>* Medical treatment with MRA / amiloride<br>* Other names: Amiloride;|
| Surgical Treatment<br>Patients with unilateral PA who underwent adrenalectomy | Procedure: Adrenalectomy<br>* Adrenalectomy for unilateral adrenal hyperplasia / adenoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Blood pressure assessed by 24hr ambulatory BP | Change from Baseline Blood Pressure at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of antihypertension medications | Use of antihypertension medications as expressed in daily defined dosages and total number of medications | Change from Baseline Antihypertension medications at 12 months | 
| Blood Pressure | Clinic blood pressure | Change from Baseline Clinic Blood Pressure at 12 months | 
| Cardiac function | Cardiac function using 2DE | Change from Baseline Cardiac function at 12 months. | 
| Left ventricular hypertrophy | as assessed by 2DE and ECG | Change from Baseline Left ventricular hypertrophy at 12 months | 
| Renal Function | change in serum creatinine, calculated GFR, albuminuria (prevalence and severity) | Change from Baseline Renal Function at 12 months | 
| Quality of Life (RAND-36) | RAND-36 | Change from Baseline Quality of Life RAND-36 at 12 months | 
| Quality of Life ( Beck's depression inventory II) | Beck's depression inventory II | Change from Baseline Quality of Life (BDI-II) at 12 months | 
| Quality of Life (EQ5D) | EQ5D | Change from Baseline EQ5D at 12 months | 
| Lipids | Lipids | Change from Baseline Lipids at 12 months | 
| Transaminitis | ALT, AST, | Change from Baseline transaminitis at 12 months | 
| Insulin Resistance | Measured with HOMA | Change from Baseline Insulin resistance at 12 months | 
| Fasting glucose | Fasting glucose | Change from Baseline Fasting glucose at 12 months | 
| weight | change in weight | Change from Baseline weight at 12 months | 
| Control of hypertension | Proportion of patients reaching normal BP (ambulatory /home BP <135/85 or clinic BP <140/90) | Change from Baseline Status of hypertension control at 12 months | 
| Cure of Primary aldosteronism | Proportion of patients with cure of PA after adrenalectomy | Change from Baseline Status of primary aldosteronism at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary aldosteronism, Blood pressure, Adrenalectomy, Mineralocorticoid-receptor Antagonists, Cardiovascular, Endothelial, Renal