Vanderbilt Clinical Trials

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.	Drug: 2-Hydroxybenzylamine 2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks. Other names: 2-HOBA
Placebo Comparator Placebo	Placebo- three tabs TID (po) for 6 weeks.	Other: Placebo Placebo 250 mg three tabs TID (po) for 6 weeks.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212

More Details

Status: Recruiting
Sponsor: Vanderbilt University Medical Center

Study Contact

Anca Ifrim, RN
6155224210
anca.ifrim@vumc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.