Outcome of Patients With Primary Aldosteronism (PA_Outcome)

• ClinicalTrials.gov Identifier: NCT04428827
• Recruitment Status: Recruiting
• First Posted: June 11, 2020
• Last Update Posted: August 12, 2021
• Sponsor: Changi General Hospital
• Collaborator: Singapore General Hospital
• Information provided by (Responsible Party): Changi General Hospital

Tracking Information

• First Submitted Date: June 8, 2020
• First Posted Date: June 11, 2020
• Last Update Posted Date: August 12, 2021
• Actual Study Start Date: October 1, 2016
• Estimated Primary Completion Date: July 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 10, 2020)

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

change in systolic blood pressure

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 10, 2020)

• 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

Original Secondary Outcome Measures (submitted: June 10, 2020)

• 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
• clinical score to predict unilateral disease [ Time Frame: through study completion, an average of 5 years ]
  Identify variables that are more common in patients with unilateral disease
• clinical score to 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Outcome of Patients With Primary Aldosteronism
• Official Title: Long-term Outcomes in Patients With Primary Aldosteronism After Treatment

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with suspected primary aldosteronism managed at referral centre for suspected primary aldosteronism

Condition

• 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

Intervention

Procedure: Unilateral adrenalectomy in patients with unilateral disease

Unilateral adrenalectomy in patients with unilateral disease

Study Groups/Cohorts

• Surgery
  Patients treated with surgery
  Intervention: Procedure: Unilateral adrenalectomy in patients with unilateral disease
• Medications
  Patients treated with mineralocorticoid antagonists or potassium sparing diuretics for primary aldosteronism

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 10, 2020): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 30, 2022
• Estimated Primary Completion Date: July 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with suspected primary aldosteronism

Exclusion Criteria:

• Nil

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years to 100 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

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

• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT04428827
• Other Study ID Numbers: PA_Outcome
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Sharing of anonymised pooled data

• Current Responsible Party: Changi General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Changi General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Singapore General Hospital

Investigators

• Principal Investigator: Troy Puar, MRCP; Changi General Hospital

• PRS Account: Changi General Hospital
• Verification Date: August 2021