Clinical trial NCT04428827: Outcome of Patients With Primary Aldosteronism
Official title: Long-term Outcomes in Patients With Primary Aldosteronism After Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2020-06-11
Enrollment: 600
Sex: ALL
Minimum age (years): 14
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected primary aldosteronism managed at referral centre for suspected primary aldosteronism

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.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected primary aldosteronism

Exclusion Criteria:

* Nil

Primary outcomes:
measure: change in systolic blood pressure before and after treatment
timeFrame: six months after treatment
Secondary outcomes:
measure: change in diastolic blood pressure before and after treatment
timeFrame: six months after treatment
measure: change in systolic blood pressure before and after treatment
timeFrame: through study completion, an average of 5 years
measure: change in diastolic blood pressure before and after treatment
timeFrame: through study completion, an average of 5 years
measure: cardiovascular outcome
timeFrame: through study completion, an average of 5 years
measure: chronic kidney disease
timeFrame: through study completion, an average of 5 years
measure: Renal Progression
timeFrame: through study completion, an average of 5 years
measure: variables that predict unilateral disease
timeFrame: through study completion, an average of 5 years
measure: variables that predict blood pressure response
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Troy Puar, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.