Outcome of Patients With Primary Aldosteronism (PA_Outcome)

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ClinicalTrials.gov Identifier: NCT04428827

Recruitment Status : Recruiting

First Posted : June 11, 2020

Last Update Posted : August 12, 2021

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Singapore General Hospital

Information provided by (Responsible Party):

Changi General Hospital

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
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

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Study Type :	Observational
Estimated 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 :	October 1, 2016
Estimated Primary Completion Date :	July 30, 2022
Estimated Study Completion Date :	July 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Congenital adrenal hyperplasia due to 11-beta-hydroxylase deficiency Familial hyperaldosteronism

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease 21-hydroxylase Deficiency Congenital Adrenal Hyperplasia Hyperadrenalism

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	14 Years to 100 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

Patients with suspected primary aldosteronism

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428827

Contacts

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Contact: Troy Puar, MRCP	67888833	troy_puar@cgh.com.sg

Locations

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Singapore
Changi General Hospital	Recruiting
Singapore, Singapore, 529889
Contact: Troy Puar 67888833 troy_puar@cgh.com.sg

Sponsors and Collaborators

Changi General Hospital

Singapore General Hospital

Investigators

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Principal Investigator:	Troy Puar, MRCP	Changi General Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Changi General Hospital
ClinicalTrials.gov Identifier:	NCT04428827
Other Study ID Numbers:	PA_Outcome
First Posted:	June 11, 2020 Key Record Dates
Last Update Posted:	August 12, 2021
Last Verified:	August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	Sharing of anonymised pooled data

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Adenoma Adrenal Hyperplasia, Congenital Adrenogenital Syndrome Renal Insufficiency, Chronic Kidney Failure, Chronic Hypokalemia Hyperaldosteronism Hyperplasia Kidney Diseases Urologic Diseases Pathologic Processes Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms	Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Disorders of Sex Development Urogenital Abnormalities Congenital Abnormalities Genetic Diseases, Inborn Steroid Metabolism, Inborn Errors Metabolism, Inborn Errors Metabolic Diseases Gonadal Disorders Renal Insufficiency Water-Electrolyte Imbalance

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