Effects of Midodrine and Droxidopa on Blood Pressure in Patients with Autonomic Failure

The Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Aim 2 of RDCRN (Rare Diseases Clinical Research Network) Project 2

This study is testing if two medications, midodrine and droxidopa, can help improve blood pressure in people with autonomic failure, like those with multiple system atrophy or Parkinson's disease.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT02897063 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of two medications, midodrine and droxidopa, on abdominal blood circulation in patients suffering from autonomic failure, including conditions like multiple system atrophy and Parkinson disease. Conducted at Vanderbilt University Medical Center, the study involves a randomized, double-blind design with 34 participants divided into two groups receiving either medication or a placebo. Participants will undergo a series of tilt table tests to measure changes in blood pressure and heart rate during the study. The total duration of the study is approximately five days, including screening and testing.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 40-80 with neurogenic orthostatic hypotension due to multiple system atrophy, pure autonomic failure, or Parkinson disease.

Not a fit: Patients with supine hypertension or systemic illnesses causing autonomic neuropathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options for patients with orthostatic hypotension related to autonomic failure.

How similar studies have performed: Other studies have explored similar treatments for orthostatic hypotension, but this specific approach is novel in its focus on splanchnic capacitance.

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.

Where this trial is running

Nashville, Tennessee

• Autonomic Dysfunction Center/ Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Italo Biaggioni, MD — Vanderbilt University Medical Center
• Study coordinator: Bonnie K Black, RN

Conditions Autonomic Failure; Pure Autonomic Failure; Multiple System Atrophy; Parkinson Disease; Orthostatic Hypotension; midodrine; droxidopa; splanchnic circulation