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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04428827
Other study ID # PA_Outcome
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
Gender All
Age group 14 Years to 100 Years
Eligibility Inclusion Criteria: - Patients with suspected primary aldosteronism Exclusion Criteria: - Nil

Study Design


Related Conditions & MeSH terms


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
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