Outcome of Patients With Primary Aldosteronism

NCT04428827 | Unknown

• 1 other identifier: PA_Outcome
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• change in systolic blood pressure before and after treatment

  change in systolic blood pressure

  six months after treatment

Secondary Outcomes (8)

• change in diastolic blood pressure before and after treatment

  six months after treatment

• change in systolic blood pressure before and after treatment

  through study completion, an average of 5 years

• change in diastolic blood pressure before and after treatment

  through study completion, an average of 5 years

• cardiovascular outcome

  through study completion, an average of 5 years

• chronic kidney disease

  through study completion, an average of 5 years

Study Arms (2)

Surgery

Patients treated with surgery

Procedure: Unilateral adrenalectomy in patients with unilateral disease

Medications

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

Interventions

Unilateral adrenalectomy in patients with unilateral disease PROCEDURE

Unilateral adrenalectomy in patients with unilateral disease

Surgery

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with suspected primary aldosteronism

You may not qualify if:

• Nil

Sponsors & Collaborators

• Changi General Hospital: lead
• Singapore General Hospital: collaborator

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 33058182 DERIVED

MeSH Terms

Conditions

Hyperaldosteronism; Renal Insufficiency, Chronic; Hypokalemia

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Troy Puar, MRCP

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Troy Puar, MRCP

CONTACT

67888833; troy_puar@cgh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: October 1, 2016
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

SG (1)