Study of the Prevalence of Endogenous Hypercortisolism in Patients With Resistant Hypertension (MOMENTUM)
NCT ID: NCT06829537
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1000 participants
OBSERVATIONAL
2025-03-28
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* Or, has rHTN, defined by the American Heart Association as SBP at target or above target requiring concurrent use of 4 or more antihypertensive medications of different classes.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Corcept Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site 378
Huntington Park, California, United States
Site 406
La Jolla, California, United States
Site 538
La Jolla, California, United States
Site 041
Los Angeles, California, United States
Site 535
Northridge, California, United States
Site 379
Redondo Beach, California, United States
Site 542
Santa Maria, California, United States
Site 387
Tarzana, California, United States
Site 375
Torrance, California, United States
Site 533
Torrance, California, United States
Site 553
Cooper City, Florida, United States
Site 444
Edgewater, Florida, United States
Site 528
Maitland, Florida, United States
Site 554
Miami, Florida, United States
Site 525
Miami, Florida, United States
Site 527
Miami, Florida, United States
Site 537
Port Charlotte, Florida, United States
Site 009
Atlanta, Georgia, United States
Site 552
Chicago, Illinois, United States
Site 532
Winfield, Illinois, United States
Site 046
Covington, Kentucky, United States
Site 061
Metairie, Louisiana, United States
Site 377
New Orleans, Louisiana, United States
Site 410
Baltimore, Maryland, United States
Site 394
Olney, Maryland, United States
Site 440
Rockville, Maryland, United States
Site 067
Boston, Massachusetts, United States
Site 530
Troy, Michigan, United States
Site 371
Las Vegas, Nevada, United States
Site 541
Reno, Nevada, United States
Site 070
Albany, New York, United States
Site 524
New York, New York, United States
Site 181
Chapel Hill, North Carolina, United States
Site 536
Durham, North Carolina, United States
Site 555
Greenville, North Carolina, United States
Site 529
Mooresville, North Carolina, United States
Site 540
Morrisville, North Carolina, United States
Site 059
Wilmington, North Carolina, United States
Site 436
Cincinnati, Ohio, United States
Site 551
Cleveland, Ohio, United States
Site 042
Cleveland, Ohio, United States
Site 195
Columbus, Ohio, United States
Site 168
Charleston, South Carolina, United States
Site 534
Mt. Pleasant, South Carolina, United States
Site 456
Austin, Texas, United States
Site 370
Dallas, Texas, United States
Site 526
Houston, Texas, United States
Site 408
Lufkin, Texas, United States
Site 369
San Antonio, Texas, United States
Site 531
Weslaco, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Daniel Einhorn, MD
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Study 311
Identifier Type: -
Identifier Source: org_study_id