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

Trial ID: NCT04620382

Interventional - Phase 1 - Completed

The purpose of this study is to learn more about the effects of abdominal compression and the medication midodrine, two interventions used for the treatment of orthostatic hypotension (low blood pressure on standing), on hemodynamic markers of cardiovascular risk. The study will be conducted at the Vanderbilt University Medical Center and consists of a screening and 2 testing days, one with abdominal compression and one with midodrine. The total length of the study will be about 5 days.

Conditions

• Neurogenic Orthostatic Hypotension
• Autonomic Failure
• Pure Autonomic Failure
• Multiple System Atrophy
• Parkinson Disease

Interventions

• Midodrine
• Placebo pill
• Abdominal compression
• sham compression

Eligibility

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

Sponsor

Vanderbilt University Medical Center, National Heart, Lung, and Blood Institute (NHLBI)

Source: ClinicalTrials.gov

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