Outcome of Patients With Primary Aldosteronism

Primary Aldosteronism Clinical Trial

— PA_Outcome  

Official title:

Long-term Outcomes in Patients With Primary Aldosteronism After Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04428827
• Other study ID #: PA_Outcome
• Status: Recruiting
• Start date: October 1, 2016
• Est. completion date: July 30, 2022

Study information

• Verified date: August 2021
• Source: Changi General Hospital
• Contact: Troy Puar, MRCP
• Phone: 67888833
• Email: troy_puar[@]cgh.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Gender: All
• Age group: 14 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients with suspected primary aldosteronism

Exclusion Criteria:

• Nil

Related Conditions & MeSH terms

• Adenoma
• Adrenal Hyperplasia, Congenital
• Adrenalectomy; Status
• Adrenogenital Syndrome
• Cardiovascular Morbidity
• Chronic Renal Disease
• Hyperaldosteronism
• Hyperplasia
• Hypokalemia
• Kidney Failure, Chronic
• Mineralocorticoid Antagonists [Aldosterone Antagonists] Causing Adverse Effects in Therapeutic Use
• Mineralocorticoid Excess
• Primary Aldosteronism
• Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
• Primary Aldosteronism Due to Aldosterone Producing Adenoma
• Renal Insufficiency, Chronic

Intervention

Procedure:
• Unilateral adrenalectomy in patients with unilateral disease
Unilateral adrenalectomy in patients with unilateral disease

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Changi General Hospital	Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

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