Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Sep 9, 2016

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two medications, midodrine and droxidopa, on patients with a condition called autonomic failure, which can cause low blood pressure when standing up. The trial aims to see how these medications affect the veins in the abdomen and is taking place at Vanderbilt University Medical Center. It includes about 34 participants who are between the ages of 40 and 80 and have specific types of autonomic failure, such as Multiple System Atrophy or Parkinson's disease. To be eligible, participants need to experience a significant drop in blood pressure when standing and must not have certain health conditions that could interfere with the study.

Participants in the trial can expect to spend about five days at the medical center, which includes screening and two testing days. They will undergo tests to monitor the effects of the medications on their condition. It’s important to note that individuals with high blood pressure, recent surgeries, or certain health issues will not be able to participate. This study could help improve treatment options for those with autonomic failure and related conditions.

Gender

ALL

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.