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NCT Number: NCT03174847

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

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.

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral) Primary Aldosteronism Due to Aldosterone Producing Adenoma

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changi General Hospital

Singapore, 529889

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adrenalectomy

Procedure

Adrenalectomy for unilateral adrenal hyperplasia / adenoma

Mineralocorticoid Receptor Antagonists

Drug

Medical treatment with MRA / amiloride

Other names: Spironolactone, Eplerenone, Amiloride

Primary outcomes

  1. Blood Pressure

    Time frame: Change from Baseline Blood Pressure at 12 months

    Blood pressure assessed by 24hr ambulatory BP

Secondary outcomes

  1. Use of antihypertension medications

    Time frame: Change from Baseline Antihypertension medications at 12 months

    Use of antihypertension medications as expressed in daily defined dosages and total number of medications

  2. Blood Pressure

    Time frame: Change from Baseline Clinic Blood Pressure at 12 months

    Clinic blood pressure

  3. Cardiac function

    Time frame: Change from Baseline Cardiac function at 12 months.

    Cardiac function using 2DE

  4. Left ventricular hypertrophy

    Time frame: Change from Baseline Left ventricular hypertrophy at 12 months

    as assessed by 2DE and ECG

  5. Renal Function

    Time frame: Change from Baseline Renal Function at 12 months

    change in serum creatinine, calculated GFR, albuminuria (prevalence and severity)

  6. Quality of Life (RAND-36)

    Time frame: Change from Baseline Quality of Life RAND-36 at 12 months

    RAND-36

  7. Quality of Life ( Beck's depression inventory II)

    Time frame: Change from Baseline Quality of Life (BDI-II) at 12 months

    Beck's depression inventory II

  8. Quality of Life (EQ5D)

    Time frame: Change from Baseline EQ5D at 12 months

    EQ5D

  9. Lipids

    Time frame: Change from Baseline Lipids at 12 months

    Lipids

  10. Transaminitis

    Time frame: Change from Baseline transaminitis at 12 months

    ALT, AST,

  11. Insulin Resistance

    Time frame: Change from Baseline Insulin resistance at 12 months

    Measured with HOMA

  12. Fasting glucose

    Time frame: Change from Baseline Fasting glucose at 12 months

    Fasting glucose

  13. weight

    Time frame: Change from Baseline weight at 12 months

    change in weight

  14. Control of hypertension

    Time frame: Change from Baseline Status of hypertension control at 12 months

    Proportion of patients reaching normal BP (ambulatory /home BP <135/85 or clinic BP <140/90)

  15. Cure of Primary aldosteronism

    Time frame: Change from Baseline Status of primary aldosteronism at 12 months

    Proportion of patients with cure of PA after adrenalectomy

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study title

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

Acronym: PA_PACES

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 5, 2017
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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