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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03174847
Other study ID # PA_PACES
Secondary ID CHF2016.02-P
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Recruiting NCT06047912 - Screening for Primary Aldosteronism in Hypertension With 24-hour URinary aLdosterone
Recruiting NCT04991961 - Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Screening for Primary Aldosteronism
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Recruiting NCT05405101 - Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA N/A
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Enrolling by invitation NCT02257450 - Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study N/A
Recruiting NCT05561361 - The Effect of SAAE on Vascular Endothelial Function in PA Patients
Completed NCT03398785 - Adrenal Artery Ablation Treats Primary Aldosteronism Phase 3
Recruiting NCT04428827 - Outcome of Patients With Primary Aldosteronism
Recruiting NCT03224312 - Chongqing Primary Aldosteronism Study