Comparing Midodrine and Abdominal Compression for Treating Low Blood Pressure in Autonomic Failure Patients
Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients
This study is testing whether the medication midodrine or abdominal compression can help people with low blood pressure due to autonomic failure feel better when they stand up.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT04620382 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of midodrine, a medication, and abdominal compression on cardiovascular risk markers in patients with autonomic failure, including conditions like neurogenic orthostatic hypotension and Parkinson's disease. Participants will undergo screening tests followed by two testing days where they will receive either midodrine or a placebo, combined with either active or sham abdominal compression. The study aims to measure various hemodynamic parameters and assess the effectiveness of these interventions in improving blood pressure regulation upon standing.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 40-80 with autonomic failure and neurogenic orthostatic hypotension.
Not a fit: Patients with contraindications to abdominal compression or those with sustained supine hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new treatment options for patients suffering from low blood pressure due to autonomic failure.
How similar studies have performed: Other studies have explored similar interventions for orthostatic hypotension, but this specific comparison of midodrine and abdominal compression is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Luis Okamoto, MD — Vanderbilt University Medical Center
- Study coordinator: Bonnie K Black, RN
- Email: bonnie.black@vumc.org
- Phone: 615-343-6862
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.