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

Description

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.

Conditions

Familial Hypercholesterolemia

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Study Overview

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Study Details

Study 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.

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

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

Condition
Familial Hypercholesterolemia
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Individuals with heterozygous Familial Hypercholesterolemia.
  • * 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.

Ages Eligible for Study

18 Years to 69 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

MacRae F. Linton, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

2025-11