Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Conditions
Keywords
Primary aldosteronism, Blood pressure, Adrenalectomy, Mineralocorticoid-receptor Antagonists, Cardiovascular, Endothelial, Renal
Brief summary
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.
Interventions
PROCEDUREAdrenalectomy
Adrenalectomy for unilateral adrenal hyperplasia / adenoma
DRUGMineralocorticoid Receptor Antagonists
Medical treatment with MRA / amiloride
Sponsors
Changi General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Change from Baseline Blood Pressure at 12 months | Blood pressure assessed by 24hr ambulatory BP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Change from Baseline Clinic Blood Pressure at 12 months | Clinic blood pressure |
| Cardiac function | Change from Baseline Cardiac function at 12 months. | Cardiac function using 2DE |
| Left ventricular hypertrophy | Change from Baseline Left ventricular hypertrophy at 12 months | as assessed by 2DE and ECG |
| Renal Function | Change from Baseline Renal Function at 12 months | change in serum creatinine, calculated GFR, albuminuria (prevalence and severity) |
| Quality of Life (RAND-36) | Change from Baseline Quality of Life RAND-36 at 12 months | RAND-36 |
| Quality of Life ( Beck's depression inventory II) | Change from Baseline Quality of Life (BDI-II) at 12 months | Beck's depression inventory II |
| Quality of Life (EQ5D) | Change from Baseline EQ5D at 12 months | EQ5D |
| Use of antihypertension medications | Change from Baseline Antihypertension medications at 12 months | Use of antihypertension medications as expressed in daily defined dosages and total number of medications |
| Transaminitis | Change from Baseline transaminitis at 12 months | ALT, AST, |
| Insulin Resistance | Change from Baseline Insulin resistance at 12 months | Measured with HOMA |
| Fasting glucose | Change from Baseline Fasting glucose at 12 months | Fasting glucose |
| weight | Change from Baseline weight at 12 months | change in weight |
| Control of hypertension | Change from Baseline Status of hypertension control at 12 months | Proportion of patients reaching normal BP (ambulatory /home BP \<135/85 or clinic BP \<140/90) |
| Cure of Primary aldosteronism | Change from Baseline Status of primary aldosteronism at 12 months | Proportion of patients with cure of PA after adrenalectomy |
| Lipids | Change from Baseline Lipids at 12 months | Lipids |
Countries
Singapore
Outcome results
None listed