Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate

Last updated: May 28, 2021
Sponsor: Changi General Hospital
Overall Status: Completed

Phase

1

Condition

Vascular Diseases

Williams Syndrome

Stress

Treatment

N/A

Clinical Study ID

NCT03990701
PA_CURE
  • Ages 21-70
  • All Genders

Study Summary

10% of patients with hypertension potentially have the treatable condition - primary aldosteronism. Primary aldosteronism (PA) is caused by either bilateral adrenal disease (40%), managed with lifelong medications; or unilateral disease (60%), cured with laparoscopic surgery (adrenalectomy). Unfortunately, many patients with curable hypertension remain undiagnosed and consequently develop cardiac disease and strokes. The difficulty with identifying curable unilateral disease is due to adrenal vein sampling (AVS): an invasive, and technically-difficult procedure, with inconclusive results in 50% of patients. An alternative novel imaging, 11C-metomidate Positron emission tomography-computed tomography (PET-CT), can detect adrenal tumors, and concurrently confirm their over-activity. It is non-invasive, non-operator-dependent, and can identify more patients with curable hypertension.

Investigators hypothesize that 11C-metomidate PET-CT can accurately identify patients with surgically-curable unilateral adrenal disease among hypertensive Asians with primary aldosteronism.

Eligibility Criteria

Inclusion

Inclusion Criteria:

• Primary aldosteronism, as defined in Endocrine Society Guidelines 2016, with positiveconfirmatory test (post-salt loading aldosterone >140pmol/L); or hypokalemia withundetectable renin levels and aldosterone >550pmol/L.

Exclusion

Exclusion Criteria:

  • Inability to provide written informed consent
  • < 21 years or > 70 years
  • Chronic renal failure of Stage 3b or greater severity
  • Severe or terminal medical condition(s)
  • Contraindications to isotope scanning or CT Scan
  • Contraindication to ingestion of corticosteroids

Study Design

Total Participants: 25
Study Start date:
May 21, 2018
Estimated Completion Date:
March 30, 2021

Study Description

25 patients with confirmed PA who are keen for a surgical cure if unilateral PA is confirmed, will undergo conventional tests, CT, AVS, as well as 11C-metomidate PET/CT.

Results will be reviewed and discussed at a multidisciplinary meeting, and patients with unilateral PA will be offered surgery. Patients will be reviewed 6 months post surgery to assess for cure of PA.

Connect with a study center

  • Changi General Hospital

    Singapore, 529889
    Singapore

    Site Not Available

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