PA_Outcome: Outcome of Patients With Primary Aldosteronism

Sponsor

Changi General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04428827

Collaborator

Singapore General Hospital (Other)

600

Enrollment

Location

69.9

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Long-term Outcomes in Patients With Primary Aldosteronism After Treatment

Actual Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Surgery Patients treated with surgery	Procedure: Unilateral adrenalectomy in patients with unilateral disease Unilateral adrenalectomy in patients with unilateral disease
Medications Patients treated with mineralocorticoid antagonists or potassium sparing diuretics for primary aldosteronism

Arm

Intervention/Treatment

Surgery

Patients treated with surgery

Procedure: Unilateral adrenalectomy in patients with unilateral disease

Unilateral adrenalectomy in patients with unilateral disease

Medications

Patients treated with mineralocorticoid antagonists or potassium sparing diuretics for primary aldosteronism

Outcome Measures

Primary Outcome Measures

change in systolic blood pressure before and after treatment [six months after treatment]
change in systolic blood pressure

Secondary Outcome Measures

change in diastolic blood pressure before and after treatment [six months after treatment]
change in diastolic blood pressure
change in systolic blood pressure before and after treatment [through study completion, an average of 5 years]
change in systolic blood pressure
change in diastolic blood pressure before and after treatment [through study completion, an average of 5 years]
change in diastolic blood pressure
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
Renal Progression [through study completion, an average of 5 years]
rate of decline of glomerular filtration rate
variables that predict unilateral disease [through study completion, an average of 5 years]
Identify variables that are more common in patients with unilateral disease
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