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NCT Number: NCT07195903

The STAND-UP Study

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Francis Hospital The Heart Center

Roslyn, New York, 11576, United States

Location status: Recruiting

Location contact

Elizabeth Haag

CONTACT

516-622-4512

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years
  • Diagnosed orthostatic intolerance or orthostatic hypotension not responding to standard medical management or complicated by supine hypertension
  • Able to provide informed consent • Exclusion criteria:
  • Pregnancy or breastfeeding 2. Active infection 3. Coagulopathy or contraindication to anticoagulation therapy

Treatment and study plan

Angioplasty or stenting

Device

Jugular Vein Stenting

Other names: Venous Stenting

Primary outcomes

  1. Blood Pressure

    Time frame: From enrollment to 6 months after

    Orthostatic blood pressures are measured and medication use is addressed

Study contacts

Contact information is provided by the study sponsor or research team.

Karthikeyan M Arcot, MD

CONTACT

[email protected]

516-612-9409

Sponsors and collaborators

Lead sponsor

St. Francis Hospital, New York

Other

Registry information

Official study title

Evaluation of Supracardiac Venous Angioplasty and Stenting on Ortho- Static Intolerance and Orthostatic Hypotension - The STANDUP Study

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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