Clinical trial NCT03174847: Prospective Study Assessing Blood Pressure and Other Outcomes Post-treatment in Patients With Primary Aldosteronism
Official title: Prospective Study Assessing Blood Pressure, Cardiovascular, Endothelial and Other Outcomes poSt-surgical and Medical Treatment in Patients With Primary Aldosteronism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Aldosteronism
Primary Aldosteronism Due to Aldosterone Producing Adenoma
Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Keywords: Primary aldosteronism
Blood pressure
Adrenalectomy
Mineralocorticoid-receptor Antagonists
Cardiovascular
Endothelial
Renal
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 57
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with confirmed primary aldosteronism

Brief summary: Majority of patients with hypertension have primary hypertension (without an underlying cause). Secondary hypertension (due to an underlying disease) is important to recognize, as treatment can lead to cure of hypertension. 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). Distinction between two is crucial as unilateral disease is treated with the aim of cure by surgery, and bilateral disease is treated by medication.

It has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, diabetes and quality of life. This is supported by studies showing reversal of these effects after treatment for PA. In addition, improvements after surgery appears to be superior to medical treatment, although studies have found variable results.

Hence, the investigators aim to accurately subtype patients with PA into unilateral or bilateral disease and study the post-treatment response after both surgery and medicine with regards to the effects on blood pressure, cardiovascular, renal, metabolic and quality of life.


Eligibility criteria: Inclusion Criteria:

i. Legally capacitated ii. 21-80 years iii. Diagnosed with primary aldosteronism iv. Patient is willing, or has undergone, adrenal surgery (in case of unilateral disease), or medical treatment (if not keen for surgery, medically unfit, or has bilateral disease)

Exclusion Criteria:

i. Unable to give consent ii. \< 21 years or \> 80 years iii. Glucocorticoid remediable aldosteronism iv. Adrenal Carcinoma v. Severe or terminal medical condition(s) that in the view of the investigator prohibits participation in the study or interferes with possible treatment or health-related quality of life, e.g. cancer, end-stage liver disease, end stage renal failure vi. Female patients who are pregnant, intending to become pregnant or breastfeeding

Primary outcomes:
measure: Blood Pressure
timeFrame: Change from Baseline Blood Pressure at 12 months
Secondary outcomes:
measure: Use of antihypertension medications
timeFrame: Change from Baseline Antihypertension medications at 12 months
measure: Blood Pressure
timeFrame: Change from Baseline Clinic Blood Pressure at 12 months
measure: Cardiac function
timeFrame: Change from Baseline Cardiac function at 12 months.
measure: Left ventricular hypertrophy
timeFrame: Change from Baseline Left ventricular hypertrophy at 12 months
measure: Renal Function
timeFrame: Change from Baseline Renal Function at 12 months
measure: Quality of Life (RAND-36)
timeFrame: Change from Baseline Quality of Life RAND-36 at 12 months
measure: Quality of Life ( Beck's depression inventory II)
timeFrame: Change from Baseline Quality of Life (BDI-II) at 12 months
measure: Quality of Life (EQ5D)
timeFrame: Change from Baseline EQ5D at 12 months
measure: Lipids
timeFrame: Change from Baseline Lipids at 12 months
measure: Transaminitis
timeFrame: Change from Baseline transaminitis at 12 months
measure: Insulin Resistance
timeFrame: Change from Baseline Insulin resistance at 12 months
measure: Fasting glucose
timeFrame: Change from Baseline Fasting glucose at 12 months
measure: weight
timeFrame: Change from Baseline weight at 12 months
measure: Control of hypertension
timeFrame: Change from Baseline Status of hypertension control at 12 months
measure: Cure of Primary aldosteronism
timeFrame: Change from Baseline Status of primary aldosteronism at 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Troy Puar, MRCP (UK)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puar TH, Cheong CK, Foo RSY, Saffari SE, Tu TM, Chee MR, Zhang M, Ng KS, Wong KM, Wong A, Ng FC, Aw TC, Khoo J, Gani L, King T, Loh WJ, Soh SB, Au V, Tay TL, Tan E, Mae L, Yew J, Tan YK, Tong KL, Lee S, Chai SC. Treatment of Primary Aldosteronism and Reversal of Renin Suppression Improves Left Ventricular Systolic Function. Front Endocrinol (Lausanne). 2022 Jun 30;13:916744. doi: 10.3389/fendo.2022.916744. eCollection 2022.