Status:
NOT_YET_RECRUITING
Clinical Trial of 2-HOBA in Pulmonary Arterial Hypertension
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
Pulmonary Hypertension (PH) is a disease in which gradual cellular occlusion of the blood vessels in the lungs increases pulmonary vascular resistance, eventually leading to right heart failure and de...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06176118
Start Date
December 1 2025
End Date
July 1 2027
Last Update
June 6 2025
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