Outcome of Patients With Primary Aldosteronism (PA_Outcome)

Long-term Outcomes in Patients With Primary Aldosteronism After Treatment

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Troy Puar, MRCP; Phone Number: 67888833; Email: troy_puar@cgh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Recruiting
    • Changi General Hospital
    • Contact: Troy Puar; Phone Number: 67888833; Email: troy_puar@cgh.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected primary aldosteronism managed at referral centre for suspected primary aldosteronism

Description

Inclusion Criteria:

• Patients with suspected primary aldosteronism

Exclusion Criteria:

• Nil

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in systolic blood pressure before and after treatment	change in systolic blood pressure	six months after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Changi General Hospital
• Collaborators: Singapore General Hospital
• Investigators: Principal Investigator: Troy Puar, MRCP, Changi General Hospital

Publications and helpful links

General Publications

• Puar TH, Loh LM, Loh WJ, Lim DST, Zhang M, Tan PT, Lee L, Swee DS, Khoo J, Tay D, Tan SY, Zhu L, Gani L, King TF, Kek PC, Foo RS. Outcomes in unilateral primary aldosteronism after surgical or medical therapy. Clin Endocrinol (Oxf). 2021 Feb;94(2):158-167. doi: 10.1111/cen.14351. Epub 2020 Oct 26.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Neoplasms by Histologic Type; Neoplasms; Kidney Diseases; Urologic Diseases; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Renal Insufficiency; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Water-Electrolyte Imbalance; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Steroid Metabolism, Inborn Errors; Renal Insufficiency, Chronic; Adenoma; Hyperplasia; Kidney Failure, Chronic; Hyperaldosteronism; Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Hypokalemia
• Other Study ID Numbers: PA_Outcome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Sharing of anonymised pooled data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No