Clinical Trial of 2-HOBA in Pulmonary Arterial Hypertension
Starting soon · Phase 2
Conditions studied: Pulmonary Arterial Hypertension
In brief
Based on existing literature and clinical trials, 2- hydroxbenzylamine (2-HOBA) has clear impact on mechanisms that much of the international field of pulmonary hypertension (PH) research agrees are central to disease progression. The investigator's preliminary data and Phase I studies demonstrate not only a clear positive impact on reducing pulmonary vascular resistances in Group I and II PH, and both cytokine and molecular biomarkers of disease, but also indicated the potential for a substantial positive effect on heart function under load stress. In this Phase II project, investigators will test the safety and efficacy of 2-HOBA in PH patients, improving the function of the right ventricle under stress in a large animal model, and effectiveness in the context of standard-of-care in mouse models and large animals, to establish the remaining data needed to proceed to commercialization.
Key facts
- Study ID
- NCT06176118
- Run by
- Vanderbilt University Medical Center
- People needed
- 12
- Starts
- 2026-09-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged 18 or older
- Diagnosed with idiopathic, heritable, simple congenital heart defect, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
- Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.
- FEV1> or = 60% predicted and no more than mild abnormalities on lung imaging
- WHO Functional Class II-IV
- Ambulatory
You may not qualify if…
- Sensitivity to 2-HOBA
- Sensitivity to aspirin or salicylates
- Aspirin-related rhinitis or wheezing
- Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity
- Pregnancy
- Diagnosis of PAH etiology other than idiopathic, heritable, simple congenital heart defect, or associated with drugs or toxins
- Drug and toxin associated PAH patients with active drug use
- Prior diagnosis of cirrhosis
- Malignancy
- eGFR by MDRD <60mL/min
- Non-english speaking
Full record on ClinicalTrials.gov
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