Clinical Trial of 2-HOBA in Pulmonary Arterial Hypertension

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Dec 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called 2-hydroxbenzylamine (2-HOBA) for people with pulmonary arterial hypertension (PAH), a serious condition that affects the blood vessels in the lungs and makes it hard for the heart to pump blood. The trial aims to determine if 2-HOBA is safe and effective in improving heart function and reducing stress on the heart in patients with PAH. Researchers will also look at how well this treatment works alongside standard medications currently used for PAH.

To participate in the trial, individuals need to be at least 18 years old and diagnosed with specific types of PAH. They should have been stable on their PAH medications for at least three months and can still walk on their own. However, individuals with certain health issues, like severe lung problems or who are pregnant, will not be eligible. This trial is not yet recruiting participants, but if you meet the criteria, it could be an opportunity to contribute to important research and potentially benefit from a new treatment. Participants will receive close monitoring and care throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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