Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT06801249

Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-30

50

Participants Needed

3

Research Sites

207 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome

CONDITIONS

Official Title

Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Unilateral or bilateral adrenal nodules with benign features and adrenal arm thickening over 5 mm on abdominal CT scan
  • Subclinical Cushing's syndrome confirmed twice in the last 6 months by specific cortisol and ACTH test results
  • Hypertension defined as blood pressure 60/90 mmHg or ongoing antihypertensive treatment
  • Patients who are not eligible for surgery
  • Signed informed consent
  • Blood pressure between 100/60 mmHg and 130/85 mmHg on the lowest effective antihypertensive therapy dose within 6-10 months after enrollment
Not Eligible

You will not qualify if you...

  • Body mass index 40 kg/m2 or higher
  • Pregnant or lactating women
  • Women of childbearing age not using barrier contraception methods
  • Steroid treatment in the last year before enrollment
  • Use of medications that interfere with Metirapone
  • Known or suspected allergy to Metirapone or related drugs
  • Serious clinical conditions that contraindicate study participation
  • Primary adrenal insufficiency, impaired adrenal secretion, or severe hypopituitarism
  • Impaired liver function
  • Untreated hypothyroidism or treatment affecting the hypothalamic-pituitary-adrenal axis
  • Hypersensitivity to Metirapone or its excipients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

2

Azienda Ospedaliera Universitaria Federico II

Naples, Italy, 80131

Actively Recruiting

3

Azienda Ospedale-Università Padova

Padova, Italy, 35128

Actively Recruiting

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Research Team

G

Guido Di Dalmazi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome | DecenTrialz