RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-14
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04941599

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.

Ages Eligible for Study:18 Years to 69 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals with heterozygous Familial Hypercholesterolemia.
  1. * Myocardial infarction or stroke within the last 6 months
  2. * unstable angina, symptoms of angina within the last 3 months
  3. * NYHA class III or IV heart failure or LVEF \< 30%
  4. * poorly controlled hypertension: SBP \> 180 mm Hg or DBP \> 110 mm Hg,
  5. * pregnancy,
  6. * evidence of a previous acute coronary syndrome,
  7. * current smokers,
  8. * individuals with Type 2 Diabetes Mellitus, obesity (BMI \> 30),
  9. * hypertriglyceridemia (fasting TG \> 250 mg/dl),
  10. * renal insufficiency (Cr \> 1.8),
  11. * hepatic disease (aspartate aminotransferase(AST) or alanine aminotransferase (ALT) \> 2x ULN),
  12. * hypothyroidism,
  13. * nephrotic syndrome,
  14. * rheumatoid arthritis,
  15. * systemic lupus erythematosus,
  16. * AIDS or HIV
  17. * history of malignancy of any organ in last 5 years.

Contacts and Locations

Study Contact

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

Principal Investigator

MacRae F. Linton, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-14
Study Completion Date2025-11

Study Record Updates

Study Start Date2024-02-14
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

  • Familial Hypercholesterolemia
  • HDL
  • LDL
  • 2-HOBA
  • HDL Function

Additional Relevant MeSH Terms

  • Familial Hypercholesterolemia