NCT03513770 Autonomic Control of the Circulation and VDR
| NCT ID | NCT03513770 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Milton S. Hershey Medical Center |
| Condition | Venous Distension Reflex |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2019-08-14 |
| Primary Completion | 2026-11-01 |
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.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2019-08-14 with a primary completion date of 2026-11-01.
⚠ 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
The study objective of this project is to examine the mechanisms of the venous distension reflex (VDR) in humans. We hypothesize that COX blockade with ketorolac tromethamine, an intravenous NSAID, will attenuate the muscle sympathetic nerve activity (MSNA) response to limb venous distension. To gain further insight into whether the COX byproducts directly stimulate chemically-sensitive afferents, or enable venodilation and indirectly evoke afferent stimulation, we will measure vein size using 3T MRI during venous distention with and without ketorolac infusions.
Eligibility Criteria
Inclusion Criteria * Are capable of giving informed consent * Are any race or ethnicity * Are fluent in written and spoken English * Have a satisfactory history and physical exam to meet inclusion/exclusion criteria * Are free of acute or chronic medical conditions * Are 21 - 35 years of age (inclusive) * Weigh over 50 kg Exclusion Criteria * Are less than 21 or over 35 years of age * Are Pregnant or nursing women * Are prisoners or institutionalized individuals or unable to consent * Any chronic diseases (hypertension, heart, lung, neuromuscular disease, kidney disease, diabetes or cancer). * Are taking medications that may affect their cardiovascular or nervous system * Has taken an NSAID within 48 hours of any visit (visit will need to be rescheduled) * Has never taken NSAIDs and therefore would not know if they are allergic to it * Have a supine BP \>140/90 mmHg * Have known allergy to ibuprofen-like drugs (NSAIDS) or aspirin * Have history of asthma or nasal polyps * Have history of GI bleeding or ulcers * Subjects with ferromagnetic metal implants * Subjects who are claustrophobic
Frequently Asked Questions
Who can join the NCT03513770 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 35 Years, studying Venous Distension Reflex. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03513770 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03513770 currently recruiting?
Yes, NCT03513770 is actively recruiting participants. Visit ClinicalTrials.gov or contact Milton S. Hershey Medical Center to inquire about joining.
Where is the NCT03513770 trial being conducted?
This trial is being conducted at Hershey, United States.
Who is sponsoring the NCT03513770 clinical trial?
NCT03513770 is sponsored by Milton S. Hershey Medical Center. The trial plans to enroll 18 participants.