Prospective Study Assessing Blood Pressure and Other Outcomes Post-treatment in Patients With Primary Aldosteronism

Primary Aldosteronism Clinical Trial

— PA_PACES  

Official title:

Prospective Study Assessing Blood Pressure, Cardiovascular, Endothelial and Other Outcomes poSt-surgical and Medical Treatment in Patients With Primary Aldosteronism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174847
• Other study ID #: PA_PACES
• Secondary ID: CHF2016.02-P
• Status: Completed
• Start date: February 20, 2017
• Est. completion date: September 20, 2020

Study information

• Verified date: May 2022
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 20, 2020
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adrenal Hyperplasia, Congenital
• Adrenogenital Syndrome
• Hyperaldosteronism
• Hyperplasia
• Primary Aldosteronism
• Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
• Primary Aldosteronism Due to Aldosterone Producing Adenoma

Intervention

Procedure:
• Adrenalectomy
Adrenalectomy for unilateral adrenal hyperplasia / adenoma

Drug:
• Mineralocorticoid Receptor Antagonists
Medical treatment with MRA / amiloride

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Blood pressure assessed by 24hr ambulatory BP	Change from Baseline Blood Pressure at 12 months
Secondary	Use of antihypertension medications	Use of antihypertension medications as expressed in daily defined dosages and total number of medications	Change from Baseline Antihypertension medications at 12 months
Secondary	Blood Pressure	Clinic blood pressure	Change from Baseline Clinic Blood Pressure at 12 months
Secondary	Cardiac function	Cardiac function using 2DE	Change from Baseline Cardiac function at 12 months.
Secondary	Left ventricular hypertrophy	as assessed by 2DE and ECG	Change from Baseline Left ventricular hypertrophy at 12 months
Secondary	Renal Function	change in serum creatinine, calculated GFR, albuminuria (prevalence and severity)	Change from Baseline Renal Function at 12 months
Secondary	Quality of Life (RAND-36)	RAND-36	Change from Baseline Quality of Life RAND-36 at 12 months
Secondary	Quality of Life ( Beck's depression inventory II)	Beck's depression inventory II	Change from Baseline Quality of Life (BDI-II) at 12 months
Secondary	Quality of Life (EQ5D)	EQ5D	Change from Baseline EQ5D at 12 months
Secondary	Lipids	Lipids	Change from Baseline Lipids at 12 months
Secondary	Transaminitis	ALT, AST,	Change from Baseline transaminitis at 12 months
Secondary	Insulin Resistance	Measured with HOMA	Change from Baseline Insulin resistance at 12 months
Secondary	Fasting glucose	Fasting glucose	Change from Baseline Fasting glucose at 12 months
Secondary	weight	change in weight	Change from Baseline weight at 12 months
Secondary	Control of hypertension	Proportion of patients reaching normal BP (ambulatory /home BP <135/85 or clinic BP <140/90)	Change from Baseline Status of hypertension control at 12 months
Secondary	Cure of Primary aldosteronism	Proportion of patients with cure of PA after adrenalectomy	Change from Baseline Status of primary aldosteronism at 12 months