Assessing cortisol levels in patients with resistant hypertension

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

This study is testing how common high cortisol levels are in people with resistant hypertension to better understand their connection.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Corcept Therapeutics (Industry-sponsored)
• Locations: 10 sites (Huntington Park, California and 9 other locations)
• Trial ID: NCT06829537 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the prevalence of endogenous hypercortisolism (eHC) in patients diagnosed with resistant hypertension (rHTN). Approximately 1000 participants will be enrolled across 45 sites in the United States. The study involves an initial screening visit, followed by a fasting blood draw after administering dexamethasone, and additional testing for those identified with eHC. The results will help understand the relationship between cortisol levels and resistant hypertension.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with resistant hypertension as defined by specific blood pressure and medication criteria.

Not a fit: Patients with white coat hypertension will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better identification and management of patients with resistant hypertension who may have underlying hypercortisolism.

How similar studies have performed: While studies on cortisol levels in hypertension exist, this specific approach to assessing eHC in resistant hypertension is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Each patient must meet all of the following criteria to be enrolled in the study:
* Signed and dated Institutional Review Board (IRB)-approved informed consent form (ICF) prior to any study-specific screening procedures.
* Male/female patients must be 18 years or older at the time of signing the informed consent.
* Meet either of the following criteria:
* Has rHTN, defined by the American Heart Association as BP above target (systolic ≥ 130 mmHg for purposes of this study) despite concurrent use of 3 or more antihypertensive medications from different classes at their maximally tolerated doses, and 1 of these agents is a diuretic.
* Has rHTN, defined by the American Heart Association as BP at target (systolic \< 130 mmHg) or above target requiring concurrent use of 4 or more antihypertensive medications of different classes.

Exclusion Criteria:

* Patients who meet any of the following criteria will not be permitted entry to the study:
* White coat hypertension, ie, elevated BP in the office only, as determined by the Investigator.
* Non-adherence to BP medications, as determined by the Investigator.
* Systemic glucocorticoid medications exposure (excluding inhalers or topical) within 3 months of screening. For temporary exposures to oral glucocorticoids the Medical Monitor may be consulted to determine eligibility.
* Has an historical estimated glomerular filtration rate (eGFR) \< 30.
* Has severe untreated sleep apnea as determined by the Investigator.
* Has excessive alcohol consumption (eg, \> 14 units/week for male, \> 7 units/week for female) as determined by the Investigator.
* Has severe acute psychiatric, medical, or surgical illness, as determined by the Investigator.
* Is a woman who is pregnant or lactating. For women of childbearing potential, a urine pregnancy test must be negative before doing the DST. A woman of childbearing potential includes women \< 50 years old, women whose surgical sterilization was performed \< 6 months ago, and women who have had a menstrual period in the last 12 months.
* Is a woman who is on oral contraceptive pills (OCPs). Women on OCPs may be screened but must be willing and able to stop OCPs for at least 6 weeks prior to screening assessments. OCPs can be resumed immediately after the blood draw for the DST.
* Has history of congenital adrenal hyperplasia.
* Has had the diagnosis of Cushing syndrome and/or has used or plans to use any of the following treatments for Cushing syndrome:

  • Mifepristone, metyrapone, osilodrostat, ketoconazole, fluconazole, aminoglutethimide, etomidate, octreotide, lanreotide, pasireotide, longacting octreotide or pasireotide.
* Is unable to take dexamethasone due to a history of hypersensitivity or severe reaction to dexamethasone.
* Is a staff member working directly on the study or is a family member of someone working directly on the study, including any of the Sponsor's employees, the Investigator or the site staff.

Where this trial is running

Huntington Park, California and 9 other locations

• Site 378 — Huntington Park, California, United States (Recruiting)
• Site 379 — Redondo Beach, California, United States (Recruiting)
• Site 444 — Edgewater, Florida, United States (Recruiting)
• Site 440 — Rockville, Maryland, United States (Recruiting)
• Site 536 — Durham, North Carolina, United States (Recruiting)
• Site 436 — Cincinnati, Ohio, United States (Recruiting)
• Site 456 — Austin, Texas, United States (Recruiting)
• Site 370 — Dallas, Texas, United States (Recruiting)
• Site 408 — Lufkin, Texas, United States (Recruiting)
• Site 369 — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Clinical Trial Lead

Conditions Resistant Hypertension; Hypercortisolism