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

ConditionFamilial Hypercholesterolemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-69
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals with heterozygous Familial Hypercholesterolemia.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 2-Hydroxybenzylamine

    Drug

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

  • Placebo

    Other intervention

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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: 2-Hydroxybenzylamine (2-HOBA)Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

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

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

Time frame
Baseline to week 6

Other outcomes

1

Change in HDL anti-inflammatory function in an in vitro assay of macrophage cytokine production (IL-1B, TNFa, IL-6).

Measurement of changes in LPS-stimulated macrophage cytokine production(IL-1B, TNFa, IL-6).

Time frame
Baseline to week 6
2

Change in HDL anti-oxidant function in an in vitro assay of macrophage reactive oxygen species production.

Measurement of changes in H2O2-stimulated macrophage reactive oxygen species

Time frame
Baseline to week 6
3

Change in HDL microRNA and small noncoding ribonucleic acid (sRNA) composition

HDL microRNA and sRNA will be measured through high-throughput sequencing with quantitative polymerase chain reaction (qPCR) validation.

Time frame
Baseline to week 6
4

Effects of 2-HOBA on HDL and LDL subpopulation sizes

HDL and LDL subpopulation sizes and particle numbers will be measured by NMR

Time frame
Baseline to week 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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