Prospective Study Assessing Blood Pressure and Other Outcomes Post-treatment in Patients With Primary Aldosteronism

Changi General Hospital57 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

AdrenalectomyPROCEDURE

Adrenalectomy for unilateral adrenal hyperplasia / adenoma

Mineralocorticoid Receptor AntagonistsDRUG

Medical treatment with MRA / amiloride

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Changi General Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

Blood Pressure

Blood pressure assessed by 24hr ambulatory BP

Time frame: Change from Baseline Blood Pressure at 12 months

Secondary Outcomes

Use of antihypertension medications

Use of antihypertension medications as expressed in daily defined dosages and total number of medications

Time frame: Change from Baseline Antihypertension medications at 12 months

Blood Pressure

Clinic blood pressure

Time frame: Change from Baseline Clinic Blood Pressure at 12 months

Cardiac function

Cardiac function using 2DE

Time frame: Change from Baseline Cardiac function at 12 months.

Left ventricular hypertrophy

as assessed by 2DE and ECG

Time frame: Change from Baseline Left ventricular hypertrophy at 12 months

Renal Function

change in serum creatinine, calculated GFR, albuminuria (prevalence and severity)

Time frame: Change from Baseline Renal Function at 12 months

Quality of Life (RAND-36)

RAND-36

Time frame: Change from Baseline Quality of Life RAND-36 at 12 months

Quality of Life ( Beck's depression inventory II)

Beck's depression inventory II

Time frame: Change from Baseline Quality of Life (BDI-II) at 12 months

Quality of Life (EQ5D)

EQ5D

Time frame: Change from Baseline EQ5D at 12 months

Lipids

Time frame: Change from Baseline Lipids at 12 months

Transaminitis

ALT, AST,

Time frame: Change from Baseline transaminitis at 12 months

Insulin Resistance

Measured with HOMA

Time frame: Change from Baseline Insulin resistance at 12 months

Fasting glucose

Time frame: Change from Baseline Fasting glucose at 12 months

weight

change in weight

Time frame: 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)

Time frame: Change from Baseline Status of hypertension control at 12 months

Cure of Primary aldosteronism

Proportion of patients with cure of PA after adrenalectomy

Time frame: Change from Baseline Status of primary aldosteronism at 12 months

Data from ClinicalTrials.gov

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