NCT06829537

Study of the Prevalence of Endogenous Hypercortisolism in Patients With Resistant Hypertension (MOMENTUM)

Study of the Prevalence of Endogenous Hypercortisolism in Patients With Resistant Hypertension in the United States of America (MOMENTUM)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,143 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-interventional study to assess the prevalence of endogenous hypercortisolism (eHC) in patients with resistant hypertension (rHTN) and will enroll approximately 1000 patients at approximately 45 sites in the United States (US). Each patient will have an initial visit for screening. After eligibility is confirmed, a limited exam will be performed and demographic and medical history will be collected. Non-fasting labs and a urine collection will also be done. A second visit will be a fasting blood draw at 8 AM after taking 1 mg of dexamethasone the night before at 11 PM. Cortisol level and study labs will also be collected. After the lab results are obtained, a third visit will be scheduled only for patients with eHC and will include a non-fasting blood draw at 8 AM and scheduling of a non-contrast CT scan.

Detailed description

This is a non-interventional study enrolling approximately 1000 patients at approximately 45 sites in the (US) and will assess the prevalence of eHC in patients with rHTN. For the purpose of this study, eHC is defined by post-dexamethasone suppression test (DST) cortisol \> 1.8 μg/dL with serum dexamethasone levels ≥ 140 μg/dL in a population meeting the inclusion and exclusion criteria for this study. rHTN is defined by the American Heart Association as 1) systolic blood pressure (SBP) above target (≥ 130 mmHg for purposes of this study) despite concurrent use of 3 or more antihypertensive medications from different classes including a diuretic at their maximally tolerated doses or 2) at target or above target SBP requiring concurrent use of 4 or more antihypertensive medications from different classes. Each patient will have an initial visit for screening. After written informed consent and eligibility is confirmed including a urine pregnancy test (if applicable), blood pressure, weight, height and waist circumference will be checked, and medical history will be obtained. Non-fasting labs such as plasma renin activity, aldosterone, N-terminal-pro brain natriuretic peptide, complete blood count, high sensitivity C-reactive protein, hemoglobin A1c, and comprehensive metabolic panel will be collected. A urine test will also be performed for albumin to creatinine ratio. A second visit will be at 8 AM (± 1 hour) the morning after taking 1 mg of dexamethasone at 11 PM the night before. The blood draw must be in the fasted state and will include cortisol level, lipid panel, adrenocorticotropic hormone (ACTH), and fasting glucose. Dexamethasone level will be checked automatically for any cortisol \>1.8 μg/dL (eHC). After the DST results are obtained, a third visit will be scheduled only for patients with eHC and will include a non-fasting 8 AM blood draw for ACTH and cortisol and scheduling of a non- contrast adrenal CT scan.

Conditions

• Resistant Hypertension
• Hypercortisolism

Timeline

• Start date: 2025-03-28
• Primary completion: 2025-12-08
• Completion: 2026-01-23
• First posted: 2025-02-17
• Last updated: 2026-02-17

Locations

50 sites across 1 country: United States