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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03174847
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : October 8, 2020
Information provided by (Responsible Party):
Changi General Hospital

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.

Condition or disease Intervention/treatment
Primary Aldosteronism Primary Aldosteronism Due to Aldosterone Producing Adenoma Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral) Procedure: Adrenalectomy Drug: Mineralocorticoid Receptor Antagonists

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Assessing Blood Pressure, Cardiovascular, Endothelial and Other Outcomes poSt-surgical and Medical Treatment in Patients With Primary Aldosteronism
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Group/Cohort Intervention/treatment
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
Medical treatment with MRA / amiloride
Other Names:
  • Spironolactone
  • Eplerenone
  • Amiloride

Surgical Treatment
Patients with unilateral PA who underwent adrenalectomy
Procedure: Adrenalectomy
Adrenalectomy for unilateral adrenal hyperplasia / adenoma

Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: Change from Baseline Blood Pressure at 12 months ]
    Blood pressure assessed by 24hr ambulatory BP

Secondary Outcome Measures :
  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 ]

  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 ]

  9. Lipids [ Time Frame: Change from Baseline Lipids at 12 months ]

  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

Biospecimen Retention:   Samples With DNA
Peripheral blood samples Adrenal vein blood samples (during adrenal vein sampling) Adrenal tissue (post-adrenalectomy)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with confirmed primary aldosteronism

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03174847

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Contact: Troy Puar, MRCP(UK) 67888833

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Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: troy h puar, mrcp    +65 68503967   
Principal Investigator: Troy H Puar, MRCP         
Sponsors and Collaborators
Changi General Hospital
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Principal Investigator: Troy Puar, MRCP (UK) Changi General Hospital
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Responsible Party: Changi General Hospital Identifier: NCT03174847    
Other Study ID Numbers: PA_PACES
CHF2016.02-P ( Other Grant/Funding Number: Changi Health Fund (Ltd) )
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Changi General Hospital:
Primary aldosteronism
Blood pressure
Mineralocorticoid-receptor Antagonists
Additional relevant MeSH terms:
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Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Gonadal Disorders
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing