Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Nov 2, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how two different treatments—midodrine, a medication, and abdominal compression, which involves wearing a special device that applies pressure to the abdomen—affect heart health in patients with autonomic failure. Autonomic failure can cause a condition called neurogenic orthostatic hypotension, where people experience a significant drop in blood pressure when they stand up, leading to dizziness or fainting. The trial will take place at Vanderbilt University Medical Center and will last about 5 days, including a screening and two testing days where participants will try each treatment.

To be eligible for the study, participants should be men or women aged 40 to 80 who have specific forms of autonomic failure, like pure autonomic failure, multiple system atrophy, or Parkinson's disease, and experience neurogenic orthostatic hypotension. Participants will need to be able to provide informed consent and stand for testing. However, those who are pregnant, bedridden, or have certain medical conditions, like severe high blood pressure or recent surgeries, will not be able to join. If you choose to participate, you will undergo assessments to monitor your heart health during the testing days.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female subjects, age 40-80 years, with autonomic failure including pure autonomic failure, multiple system atrophy and Parkinson disease.
• • Neurogenic orthostatic hypotension, defined as a ≥20-mmHg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
• • Patients who are willing and able to provide informed consent
• Exclusion Criteria:
• • Pregnancy.
• • Patients with any contraindication or intolerant to abdominal compression including history of aortic aneurysms, thoracic, abdominal or pelvic surgery within 6 months of study participation; symptomatic abdominal or inguinal hernias; severe gastrointestinal 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.
• • Pre-existing sustained supine hypertension ≥180/110mmHg
• • Bedridden patients or those who are unable to stand due to motor impairment or severe OH.
• • Patients who cannot tolerate the medication withdrawal, defined as those who are unable to stand for at least one minute after the medication withdrawal period or those with sustained supine hypertension ≥180/110mmHg.
• • Clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months.
• • Clinically significant pulmonary, renal, hematopoietic, hepatic disease, or 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