ClinicalTrials.gov record NCT07195903

The STAND-UP Study

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This single-group treatment study evaluates a minimally invasive procedure to open narrowed veins above the heart (supracardiac veins) in adults with orthostatic hypotension or orthostatic intolerance that has not improved with standard medical care or is complicated by high blood pressure when lying down. Participants receive imaging to look for vein narrowing and, if found, may have venous angioplasty or stent placement. Study visits check blood pressure, symptoms, medication use, and quality of life over follow-up visits up to two years.

What it is studying. The study tests whether opening narrowed supracardiac veins with angioplasty or stenting changes orthostatic blood pressure, symptom burden, and medication use, measured before and after the procedure.

What the researchers hope to learn. To learn whether supracardiac venous angioplasty or stenting is associated with changes in orthostatic blood pressure, symptoms, and medication use, using before-and-after measurements up to two years.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • Angioplasty or stenting

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have imaging (for example X-ray and ultrasound) to look for narrowed veins above the heart. If narrowing is found, they may undergo a catheter-based procedure through a small skin puncture to widen the vein using balloon angioplasty and/or placement of a stent, typically under local anesthesia and taking a few hours. Possible risks of this procedure include bleeding, infection, blood clots, stroke, stent-related problems, and radiation exposure from imaging. Follow-up visits include checks of symptoms, standing (orthostatic) blood pressures, medication use, and quality-of-life at about 2–4 weeks, 3 months, 6 months, 1 year, and 2 years, with safety monitoring throughout.

How the study is structured. A single-group interventional (treatment) study with no masking: all enrolled adults are evaluated with imaging; those with vein narrowing may receive venous angioplasty or stenting. Outcomes (blood pressure, symptoms, medication use, quality of life) are measured at early follow-up (2–4 weeks), 3 months, 6 months, 1 year, and 2 years. There is no placebo or separate comparison group.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Orthostatic Hypotension, Dysautonomic; Orthostatic Intolerance. Does it apply to my diagnosis?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Jan 23, 2025
Primary completion
Jan 1, 2029 (estimated)
Study completion
Jan 1, 2030 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Sep 29, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
St. Francis Hospital, New York

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • St. Francis Hospital The Heart CenterRecruiting

    Roslyn, New York, 11576 · United States

Terms used on this page · explanations by MedicalUpdates.ai

Follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
study drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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