| NCT ID | NCT07195903 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Francis Hospital, New York |
| Condition | Orthostatic Hypotension, Dysautonomic |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-23 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-01-23 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Karthikeyan M Arcot, MD
PRINCIPAL INVESTIGATOR
St. Francis Hospital The Heart Center
Frequently Asked Questions
Who can join the NCT07195903 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Orthostatic Hypotension, Dysautonomic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07195903 currently recruiting?
Yes, NCT07195903 is actively recruiting participants. Contact the research team at karcot@intneuro.org for enrollment information.
Where is the NCT07195903 trial being conducted?
This trial is being conducted at Roslyn, United States.
Who is sponsoring the NCT07195903 clinical trial?
NCT07195903 is sponsored by St. Francis Hospital, New York. The principal investigator is Karthikeyan M Arcot, MD at St. Francis Hospital The Heart Center. The trial plans to enroll 100 participants.