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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Jun 18, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called 2-Hydroxybenzylamine (2-HOBA) to see if it can help people with a genetic condition known as Familial Hypercholesterolemia (FH). FH causes high cholesterol levels, which can lead to heart problems. The researchers want to find out if taking 2-HOBA can reduce harmful changes to cholesterol particles in the body and improve their function. Participants in the study will either receive 750 mg of 2-HOBA or a placebo (a substance with no active medication) every 8 hours for 6 weeks.

To be eligible for this trial, individuals must have heterozygous FH, a specific form of the condition. However, there are some important health criteria that could exclude someone from participating. For instance, people who have had a heart attack or stroke in the last 6 months, those with severe heart failure, or individuals with poorly controlled high blood pressure cannot join the trial. The study is currently looking for participants aged 18 to 75, and it welcomes individuals of all genders. If you qualify and choose to participate, you will be contributing to important research that could lead to better treatments for people with FH.

Gender

ALL

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.