2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)

Phase 2RecruitingNCT04941599

Vanderbilt University Medical Center72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Familial Hypercholesterolemia

Interventions

2-HydroxybenzylamineDRUG

2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks.

PlaceboOTHER

Placebo 250 mg three tabs TID (po) for 6 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

2-HOBA increases HDL cholesterol efflux capacity.

Change in HDL cholesterol efflux capacity will be measured by macrophage cholesterol efflux assay.

Time frame: Baseline to week 6

Secondary Outcomes

2-HOBA reduces modification of HDL by Isolevuglandin (Iso-LG).

Measurement of the Iso-LG-lysine lactam by mass spectrometry.

Time frame: Baseline to week 6

2-HOBA reduces modification of HDL by malondialdehyde (MDA).

Measurement of dilysyl-MDA cross-links by mass spectrometry.

Time frame: Baseline to week 6

Central Contacts

Anca Ifrim, RN

CONTACT

6155224210 anca.ifrim@vumc.org

Data from ClinicalTrials.gov

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