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

Completed

• Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma; Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral); Primary Aldosteronism
• Interventions: Drug: Mineralocorticoid Receptor Antagonists; Procedure: Adrenalectomy

• Registration Number: NCT03174847
• Lead Sponsor: Changi General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-05
• Primary Completion: 2019-10-20
• Study Completion: 2020-09-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medical Treatment	Mineralocorticoid Receptor Antagonists	Patients who undergo medical treatment, in view of bilateral PA, or unilateral PA not keen for surgery, or indeterminate (lack of localisation on tests)
Surgical Treatment	Adrenalectomy	Patients with unilateral PA who underwent adrenalectomy

Primary Outcome Measures

Name	Time	Method
Blood Pressure	Change from Baseline Blood Pressure at 12 months	Blood pressure assessed by 24hr ambulatory BP

Secondary Outcome Measures

Name	Time	Method
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
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
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
Fasting glucose	Change from Baseline Fasting glucose at 12 months	Fasting glucose
Renal Function	Change from Baseline Renal Function at 12 months	change in serum creatinine, calculated GFR, albuminuria (prevalence and severity)
weight	Change from Baseline weight at 12 months	change in weight
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

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore