Status:
NOT_YET_RECRUITING
HT-ENDO: A Multiomics-based Biomarker for the Diagnosis of Endocrine Hypertension: a Pragmatic, Diagnostic, Randomized, Outcome-based Trial
Lead Sponsor:
JDeinum
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Rationale: Diagnosis of endocrine forms of hypertension (primary aldosteronism, pheochromocytoma/paraganglioma and Cushing syndrome) is a lengthy and tedious process. Recently a multiomics biomarker w...
Eligibility Criteria
Inclusion
- Age 18-75 years
- Have a properly documented hypertension by abpm, hbpm, unattended office blood pressure measurement or carefully performed office measurement.
- Has a physician who feels an urge to exclude or diagnose EHT for one or more of the following reasons
- resistant hypertension AND/OR
- hypokalemia, spontaneous or diuretic-induced AND/OR
- history or physical examination suggestive of endocrine hypertension
- Willingness and ability to give informed consent
Exclusion
- White-coat hypertension
- Known renal artery stenosis
- Known licorice abuse
- Known familial form of endocrine hypertension
- Cardiovascular event (myocardial infarction, cerebrovascular event) \< 6 months \[Y/N\]
- Hypertensive crisis \< 6 months
- eGFR \< 50 ml/min/1,73m2
- Liver failure
- Known severe valvular or structural heart disease (excluding left ventricular hypertrophy)
- NYHA class III or IV heart failure or known reduced left ventricular function (ejection fraction (EF) \<30%)
- EKG demonstrating significant pathology (e.g. myocardial infarction, atrial fibrillation, or any other cardial condition prohibiting start of study medication)
- Life expancy \< 1 year
- For women, current pregnancy or unprotected intercourse
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06578975
Start Date
November 1 2024
End Date
January 1 2026
Last Update
August 30 2024
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