NCT02897063 Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
| NCT ID | NCT02897063 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Autonomic Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2016-09 |
| Primary Completion | 2026-09 |
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 34 participants in total. It began in 2016-09 with a primary completion date of 2026-09.
⚠ 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 purpose of this study is to learn more about the effects of midodrine and droxidopa, two medications used for the treatment of orthostatic hypotension (low blood pressure on standing), on the veins of the abdomen of patients with autonomic failure. The study will be conducted at Vanderbilt University Medical Center, and consists of 2 parts: a screening and 2 testing days. The total length of the study will be about 5 days. About 34 participants will be screened for the study.
Eligibility Criteria
Inclusion Criteria: * Male and female subjects, age 40-80 years with possible or probable Multiple System Atrophy, Pure Autonomic Failure, or Parkinson disease, as defined by Consensus Criteria. * Neurogenic orthostatic hypotension defined as a ≥30-mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes. * Subjects able and willing to provide informed consent. Exclusion Criteria: * Supine hypertension, defined as systolic blood pressure of ≥ 160 mmHg measured on two separate occasions. * Pregnancy. * Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies. * History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6 months. * Symptomatic abdominal or inguinal hernias. * Severe gastroesophageal reflux. * Recent fractures or fissures of ribs, thoracic or lumbar spine. * Medical devices implanted on the abdominal wall or abdomen that would interfere with the abdominal compression. * Intolerance to any increase in intraabdominal pressure. * Clinically unstable coronary artery disease or major cardiovascular or neurological event in the past 6 months, and other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing.
Contact & Investigator
Italo Biaggioni, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT02897063 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Autonomic Failure. 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 NCT02897063 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 NCT02897063 currently recruiting?
Yes, NCT02897063 is actively recruiting participants. Contact the research team at autonomics@vumc.org for enrollment information.
Where is the NCT02897063 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT02897063 clinical trial?
NCT02897063 is sponsored by Vanderbilt University Medical Center. The principal investigator is Italo Biaggioni, MD at Vanderbilt University Medical Center. The trial plans to enroll 34 participants.