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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
Sponsor:
Collaborator:
Singapore General Hospital
Information provided by (Responsible Party):
Changi General Hospital

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

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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


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



Primary Outcome Measures :
  1. change in systolic blood pressure before and after treatment [ Time Frame: six months after treatment ]
    change in systolic blood pressure


Secondary Outcome Measures :
  1. change in diastolic blood pressure before and after treatment [ Time Frame: six months after treatment ]
    change in diastolic blood pressure

  2. change in systolic blood pressure before and after treatment [ Time Frame: through study completion, an average of 5 years ]
    change in systolic blood pressure

  3. change in diastolic blood pressure before and after treatment [ Time Frame: through study completion, an average of 5 years ]
    change in diastolic blood pressure

  4. 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

  5. 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

  6. Renal Progression [ Time Frame: through study completion, an average of 5 years ]
    rate of decline of glomerular filtration rate

  7. 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

  8. 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



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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:

  • Nil

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