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

NCT06829537 | Completed

• 1 other identifier: Study 311
• Study Type: observational
• Target: 1,143
• Locations: 1 country
• Sites: 50

Brief 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.

Conditions

Resistant Hypertension; Hypercortisolism

Keywords

Hypercortisolism; Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

• To assess the prevalence of endogenous hypercortisolism in a population with resistant hypertension.

  Prevalence of endogenous hypercortisolism in a population with resistant hypertension will be described as the percentage of patients with post-DST cortisol \> 1.8 μg/dL with dexamethasone level ≥ 140 ng/dL among all patients enrolled.

  From enrollment to the end of the study which is approximately 4 weeks.

Secondary Outcomes (3)

• Assess clinical characteristics that increase the likelihood of a patient having endogenous hypercortisolism of those with and without abnormal adrenal imaging.

  From enrollment to the end of the study which is approximately 4 weeks.

• Assess laboratory characteristics that increase the likelihood of a patient having endogenous hypercortisolism of those with and without abnormal adrenal imaging.

  From enrollment to the end of the study which is approximately 4 weeks.

• Assess the likelihood of a patient having endogenous hypercortisolism of those with and without abnormal adrenal imaging.

  From enrollment to the end of the study which is approximately 4 weeks.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Office-based care and university clinics in the United States.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (50)

Site 378

Huntington Park, California, 90255, United States

Location

Site 406

La Jolla, California, 92037, United States

Location

Site 538

La Jolla, California, 92037, United States

Location

Site 041

Los Angeles, California, 90048, United States

Location

Site 535

Northridge, California, 91324, United States

Location

Site 379

Redondo Beach, California, 90247, United States

Location

Site 542

Santa Maria, California, 93454, United States

Location

Site 387

Tarzana, California, 91356, United States

Location

Site 375

Torrance, California, 90502, United States

Location

Site 533

Torrance, California, 90505, United States

Location

Site 553

Cooper City, Florida, 33024, United States

Location

Site 444

Edgewater, Florida, 32132, United States

Location

Site 528

Maitland, Florida, 32751, United States

Location

Site 554

Miami, Florida, 33126, United States

Location

Site 525

Miami, Florida, 33155, United States

Location

Site 527

Miami, Florida, 33173, United States

Location

Site 537

Port Charlotte, Florida, 33952, United States

Location

Site 009

Atlanta, Georgia, 30303, United States

Location

Site 552

Chicago, Illinois, 60607, United States

Location

Site 532

Winfield, Illinois, 60190, United States

Location

Site 046

Covington, Kentucky, 41011, United States

Location

Site 061

Metairie, Louisiana, 70006, United States

Location

Site 377

New Orleans, Louisiana, 70112, United States

Location

Site 410

Baltimore, Maryland, 21239, United States

Location

Site 394

Olney, Maryland, 20832, United States

Location

Site 440

Rockville, Maryland, 20854, United States

Location

Site 067

Boston, Massachusetts, 02115, United States

Location

Site 530

Troy, Michigan, 48085, United States

Location

Site 371

Las Vegas, Nevada, 89148, United States

Location

Site 541

Reno, Nevada, 89502, United States

Location

Site 070

Albany, New York, 12203, United States

Location

Site 524

New York, New York, 10029, United States

Location

Site 181

Chapel Hill, North Carolina, 27514, United States

Location

Site 536

Durham, North Carolina, 27701, United States

Location

Site 555

Greenville, North Carolina, 27834, United States

Location

Site 529

Mooresville, North Carolina, 28117, United States

Location

Site 540

Morrisville, North Carolina, 27560, United States

Location

Site 059

Wilmington, North Carolina, 28401, United States

Location

Site 436

Cincinnati, Ohio, 45219, United States

Location

Site 551

Cleveland, Ohio, 44109, United States

Location

Site 042

Cleveland, Ohio, 44195, United States

Location

Site 195

Columbus, Ohio, 43201, United States

Location

Site 168

Charleston, South Carolina, 29425, United States

Location

Site 534

Mt. Pleasant, South Carolina, 29464, United States

Location

Site 456

Austin, Texas, 78759, United States

Location

Site 370

Dallas, Texas, 75230, United States

Location

Site 526

Houston, Texas, 77054, United States

Location

Site 408

Lufkin, Texas, 75904, United States

Location

Site 369

San Antonio, Texas, 78229, United States

Location

Site 531

Weslaco, Texas, 78596, United States

Location

MeSH Terms

Conditions

Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 17, 2025
• Study Start: March 28, 2025
• Primary Completion: December 8, 2025
• Study Completion: January 23, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (50)