2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
Purpose
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.
Condition
- Familial Hypercholesterolemia
Eligibility
- Eligible Ages
- Between 18 Years and 69 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Subjects will be randomized to treatment with either 2-Hydroxybenzylamine (2-HOBA) , a naturally occuring dicarbonyl scavenger, or placebo for 6 weeks.
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 2-Hydroxybenzylamine (2-HOBA) |
2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks. |
|
|
Placebo Comparator Placebo |
Placebo- three tabs TID (po) for 6 weeks. |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37212
Nashville, Tennessee 37212
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt University Medical Center