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

NCT03174847 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2022-05-20

No results posted yet for this study

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)

Interventions

PROCEDURE

Adrenalectomy

Adrenalectomy for unilateral adrenal hyperplasia / adenoma

DRUG

Mineralocorticoid Receptor Antagonists

Medical treatment with MRA / amiloride

Sponsors & Collaborators

  • Changi General Hospital

    lead OTHER

Principal Investigators

  • Troy Puar, MRCP (UK) · Changi General Hospital

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-20
Primary Completion
2019-10-20
Completion
2020-09-20

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03174847 on ClinicalTrials.gov