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Search / Trial NCT01096654

SPARTACUS: Subtyping Primary Aldosteronism: a Randomized Trial Comparing Adrenal Vein Sampling and Computed Tomography Scan.

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Mar 30, 2010

Trial Information

Current as of May 15, 2025

Completed

Keywords

Endocrine Hypertension Primary Hyperaldosteronism Aldosterone Aldosterone Producing Adenoma Bilateral Adrenal Hyperplasia Computed Tomography Adrenal Vein Sampling

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Legally capacitated;
  • ≥ 18 years of age;
  • Diagnosed with hypertension that is difficult to treat (blood pressure \> 140/90 mmHg in spite of two antihypertensive drugs in adequate doses), or accompanied by hypokalemia, either spontaneous or induced by use of diuretics;
  • patients must have a positive result on a sodium loading test (as recommended in the Endocrine Society Guideline), i.e. insufficient suppression of aldosterone.
  • Cooperating patient who is willing to undergo adrenal surgery in case of an adenoma or lateralized aldosterone secretion, who is able to comply with the study protocol and who is willing to give written informed consent.
  • Exclusion Criteria:
  • Unsuitability for or objection to undergo AVS, CT or adrenal surgery.(including pregnancy);
  • Glucocorticoid remediable aldosteronism or adrenal carcinoma;
  • Severe or terminal co-morbidity which seriously interferes with possible treatment or health related quality of life;
  • Requirement of certain medication that interacts with the prescribed treatments in this protocol or that can cause hypertension as an important side-effect e.g. glucocorticoids. Patients will only be excluded as the medication cannot be stopped or altered.

About Radboud University Medical Center

Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.

Locations

Nijmegen, Gelderland, Netherlands

Patients applied

0 patients applied

Trial Officials

Jacob Deinum, Dr.

Principal Investigator

UCM St. Radboud

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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