The STAND-UP Study

NCT07195903 | Recruiting FDA Device

• 1 other identifier: 25-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Orthostatic hypotension (OH) and orthostatic intolerance (OI) are common conditions where blood pressure drops when standing up, causing dizziness, fainting, or fatigue. These affect up to 30% of adults over 65 and raise risks for heart disease, stroke, kidney problems, and more. Current medications often don't fully help and can cause side effects like high blood pressure when lying down. The STANDUP study tests a new approach: using a minimally invasive procedure to open narrowed veins above the heart (supracardiac veins) that may block blood flow back to the heart. We believe fixing these blockages could improve blood pressure control and reduce symptoms. This is a 2-year study enrolling 100 adults (age 18+) with OH or OI that hasn't improved with standard treatments or is worsened by lying-down high blood pressure. What happens in the study? Participants get imaging (like X-rays and ultrasound) to check for vein narrowing. If needed, doctors use a thin tube (catheter) through a small skin puncture to inflate a tiny balloon (angioplasty) or place a small mesh tube (stent) to widen the veins. The procedure takes a few hours under local anesthesia, with monitoring for safety. Follow-up visits check symptoms, blood pressure, and quality of life at 2-4 weeks, 3 months, 6 months, 1 year, and 2 years. Who can join? Adults 18+ with diagnosed OH/OI not helped by meds. Must give informed consent. Not eligible if: Pregnant, breastfeeding, actively infected, or unable to take blood thinners. Possible benefits: Better standing tolerance, fewer symptoms, improved daily life, less need for meds, and new knowledge on vein issues in OH/OI. Risks: Rare but include bleeding, infection, stroke, vein clots, stent issues, radiation from imaging, or temporary symptom worsening. We'll monitor closely and report any problems. This single-arm trial (no placebo group) will compare before-and-after results to see if the procedure helps. No study drug costs; covered by insurance or clinic. Led by Dr. Karthikeyan Arcot at St. Francis Hospital, Roslyn, NY. Contact for details.

Conditions

Orthostatic Hypotension, Dysautonomic; Orthostatic Intolerance

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Orthostatic blood pressures are measured and medication use is addressed

  From enrollment to 6 months after

Study Arms (1)

Intervention

EXPERIMENTAL

Venous Angioplasty or stenting

Device: Angioplasty or stenting

Interventions

Angioplasty or stenting DEVICE

Jugular Vein Stenting

Also known as: Venous Stenting

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years
• Diagnosed orthostatic intolerance or orthostatic hypotension not responding to standard medical management or complicated by supine hypertension

You may not qualify if:

• \. Pregnancy or breastfeeding 2. Active infection 3. Coagulopathy or contraindication to anticoagulation therapy

Sponsors & Collaborators

• St. Francis Hospital, New York: lead

Study Sites (1)

St. Francis Hospital The Heart Center

Roslyn, New York, 11576, United States

RECRUITING

MeSH Terms

Conditions

Shy-Drager Syndrome; Orthostatic Intolerance

Interventions

Angioplasty; Stents

Condition Hierarchy (Ancestors)

Multiple System Atrophy; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Hypotension; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Prostheses and Implants; Equipment and Supplies

Study Officials

• Karthikeyan M Arcot, MD

  St. Francis Hospital The Heart Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karthikeyan M Arcot, MD

CONTACT

516-612-9409; karcot@intneuro.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: January 23, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)