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NCT07195903 · ClinicalTrials.gov registry record · NA
The STAND-UP Study
A NA study of Orthostatic Intolerance and Orthostatic Hypotension, Dysautonomic, sponsored by St. Francis Hospital, New York.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT07195903 is a NA study of Orthostatic Intolerance and Orthostatic Hypotension, Dysautonomic that is actively recruiting participants, run by St. Francis Hospital, New York. The registered enrollment target is 100 participants, below the 141-participant average among 5 other Orthostatic Intolerance trials with a reported enrollment target (29% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07195903, a NA study of Orthostatic Intolerance and Orthostatic Hypotension, Dysautonomic, is actively recruiting participants, sponsored by St. Francis Hospital, New York.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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 c
Conditions Studied
Interventions
- DEVICE Angioplasty or stenting
Study Locations (1)
New York
- St. Francis Hospital The Heart Center - Roslyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-01-23 |
| Est. Completion | 2030-01-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07195903
The ClinicalTrials.gov registry entry for NCT07195903 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 141-participant average among 5 other Orthostatic Intolerance trials with a reported enrollment target (29% lower). The listed sponsor is St. Francis Hospital, New York, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Orthostatic Intolerance appearing as the primary indexed condition, and to 1 intervention - of which Angioplasty or stenting is the first listed.
NCT07195903 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT07195903 about?
NCT07195903 is a clinical study titled "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...
What is the current status of trial NCT07195903?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2025-01-23. Estimated completion is 2030-01-01.
What conditions does trial NCT07195903 study?
This clinical trial studies the following conditions: Orthostatic Intolerance, Orthostatic Hypotension, Dysautonomic.
What interventions are being tested in trial NCT07195903?
The interventions under investigation include: Angioplasty or stenting (DEVICE).
Who is sponsoring clinical trial NCT07195903?
This trial is sponsored by St. Francis Hospital, New York, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07195903 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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