RecruitingPhase 2NCT04941599
2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
Sponsor
Vanderbilt University Medical Center
Enrollment
72 participants
Start Date
Feb 14, 2024
Study Type
INTERVENTIONAL
Conditions
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 with Familial Hypercholesterolemia (FH), treating them with 750 mg of 2-HOBA or placebo every 8 hours for 6 weeks.
Eligibility
Min Age: 18 YearsMax Age: 69 Years
Inclusion Criteria1
- Individuals with heterozygous Familial Hypercholesterolemia.
Exclusion Criteria17
- 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.
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Interventions
DRUG2-Hydroxybenzylamine
2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks.
OTHERPlacebo
Placebo 250 mg three tabs TID (po) for 6 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04941599
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