Evaluation of Supracardiac Venous Angioplasty and Stenting for Orthostatic Intolerance and Orthostatic Hypotension - The STANDUP Study

What this Trial Is About

Orthostatic hypotension (OH) and orthostatic intolerance (OI) are conditions where blood pressure drops upon standing, causing symptoms like dizziness, fainting, and fatigue. These affect many adults, especially those over 65, and increase the risk of heart disease, stroke, and kidney problems. Current treatments often do not fully control symptoms and can cause side effects such as high blood pressure when lying down. This study evaluates a new approach to address these problems by opening narrowed veins above the heart that may block blood flow, potentially improving blood pressure control and reducing symptoms. The study involves a minimally invasive procedure using a catheter to perform angioplasty or place a stent in narrowed supracardiac veins. This procedure is done under local anesthesia through a small puncture in the skin and takes a few hours. Participants receive imaging tests like X-rays and ultrasound to identify vein narrowing before treatment. The study lasts two years and enrolls about 100 adults aged 18 and older with OH or OI that has not improved with standard medications or is complicated by high blood pressure when lying down. This is a single-arm trial without a placebo group. Participants will have follow-up visits at 2-4 weeks, 3 months, 6 months, 1 year, and 2 years after the procedure to monitor symptoms, blood pressure, and quality of life. Researchers will measure blood pressure changes from enrollment to 6 months after treatment. Safety monitoring includes watching for possible risks such as bleeding, infection, stroke, or stent-related issues. The study covers all related care costs, and participants continue their usual medical care throughout the study period.

The STAND-UP Study