Recruiting

Angioplasty

Sponsor:

St. Francis Hospital, New York

Code:

NCT07195903

Conditions

Orthostatic Hypotension, Dysautonomic

Orthostatic Intolerance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Angioplasty or stenting

Study Details

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

Study ID

NCT07195903

Start date

Jan 23, 2025

Status verified date

Jul, 2025

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria :

1. Age 18 years
2. Diagnosed orthostatic intolerance or orthostatic hypotension not responding to standard medical management or complicated by supine hypertension
3. Able to provide informed consent • Exclusion criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Venous Angioplasty or stenting

Interventions

Angioplasty or stenting

Jugular Vein Stenting

Primary outcome measure

  • Blood Pressure [ Time Frame: From enrollment to 6 months after ]

Central Contacts and Locations

Central contacts

Karthikeyan M Arcot, MD

516-612-9409karcot@intneuro.org

Locations

St. Francis Hospital The Heart Center

Recruiting

Roslyn, New York, United States, 11576

Contacts

Elizabeth Haag

516-622-4512

More Information

Sponsor

St. Francis Hospital, New York

Last update posted

Sep 29, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Francis Hospital, New York on 2025-09-29.