Outcome of Patients With Primary Aldosteronism

• Conditions: Primary Aldosteronism; Mineralocorticoid Antagonists [Aldosterone Antagonists] Causing Adverse Effects in Therapeutic Use; Chronic Renal Disease; Primary Aldosteronism Due to Aldosterone Producing Adenoma; Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral); Mineralocorticoid Excess; Adrenalectomy; Status; Cardiovascular Morbidity; Hypokalemia
• Interventions: Procedure: Unilateral adrenalectomy in patients with unilateral disease

• Registration Number: NCT04428827
• Lead Sponsor: Changi General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-12
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patients with suspected primary aldosteronism

Exclusion Criteria

• Nil

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery	Unilateral adrenalectomy in patients with unilateral disease	Patients treated with surgery

Primary Outcome Measures

Name	Time	Method
change in systolic blood pressure before and after treatment	six months after treatment	change in systolic blood pressure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore