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

NCT03174847 | Completed

• 2 other identifiers: PA_PACESCHF2016.02-P
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Blood pressure assessed by 24hr ambulatory BP

  Change from Baseline Blood Pressure at 12 months

Secondary Outcomes (15)

• Use of antihypertension medications

  Change from Baseline Antihypertension medications at 12 months

• Blood Pressure

  Change from Baseline Clinic Blood Pressure at 12 months

• Cardiac function

  Change from Baseline Cardiac function at 12 months.

• Left ventricular hypertrophy

  Change from Baseline Left ventricular hypertrophy at 12 months

• Renal Function

  Change from Baseline Renal Function at 12 months

Study Arms (2)

Medical Treatment

Patients who undergo medical treatment, in view of bilateral PA, or unilateral PA not keen for surgery, or indeterminate (lack of localisation on tests)

Drug: Mineralocorticoid Receptor Antagonists

Surgical Treatment

Patients with unilateral PA who underwent adrenalectomy

Procedure: Adrenalectomy

Interventions

Adrenalectomy PROCEDURE

Adrenalectomy for unilateral adrenal hyperplasia / adenoma

Surgical Treatment

Mineralocorticoid Receptor Antagonists DRUG

Medical treatment with MRA / amiloride

Also known as: Spironolactone, Eplerenone, Amiloride

Medical Treatment

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with confirmed primary aldosteronism

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (1)

• 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.

  PMID: 35846272 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples Adrenal vein blood samples (during adrenal vein sampling) Adrenal tissue (post-adrenalectomy)

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Adrenalectomy; Mineralocorticoid Receptor Antagonists; Spironolactone; Eplerenone; Amiloride

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents; Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Troy Puar, MRCP (UK)

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 5, 2017
• Study Start: February 20, 2017
• Primary Completion: October 20, 2019
• Study Completion: September 20, 2020
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)