Status:
RECRUITING
2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Familial Hypercholesterolemia
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
The Investigators will test the hypothesis that 2-HOBA will reduce modification of HDL and LDL and improve HDL function in humans with heterozygous FH. The Investigators plan to first study subjects w...
Eligibility Criteria
Inclusion Criteria:
- Individuals with heterozygous Familial Hypercholesterolemia.
Exclusion Criteria:
- Myocardial infarction or stroke within the last 6 months
- unstable angina, symptoms of angina within the last 3 months
- NYHA class III or IV heart failure or LVEF < 30%
- poorly controlled hypertension: SBP > 180 mm Hg or DBP > 110 mm Hg,
- pregnancy,
- evidence of a previous acute coronary syndrome,
- current smokers,
- individuals with Type 2 Diabetes Mellitus, obesity (BMI > 30),
- hypertriglyceridemia (fasting TG > 250 mg/dl),
- renal insufficiency (Cr > 1.8),
- hepatic disease (aspartate aminotransferase(AST) or alanine aminotransferase (ALT) > 2x ULN),
- hypothyroidism,
- nephrotic syndrome,
- rheumatoid arthritis,
- systemic lupus erythematosus,
- AIDS or HIV
- history of malignancy of any organ in last 5 years.
Key Trial Info
Start Date :
February 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04941599
Start Date
February 14 2024
End Date
December 31 2026
Last Update
February 4 2026
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212