Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

Multiple System Atrophy Clinical Trial

Official title:

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02429557
• Other study ID #: 140634
• Secondary ID: 1R01HL144568-01A
• Status: Recruiting
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Bonnie K Black, RN
• Phone: 615-343-6862
• Email: autonomics[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compression garments have been shown to be effective in the treatment of orthostatic hypotension in autonomic failure patients. The purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing blood pressure and orthostatic tolerance in these patients, and to compare them with those of the standard of care midodrine. The investigators will test the hypothesis that abdominal compression will blunt the exaggerated fall in stroke volume and the increase in abdominal vascular volume during head up tilt.

Description:

Patients with autonomic failure are characterized by disabling orthostatic hypotension (low blood pressure on standing) due to severe impairment of the autonomic nervous system. Compression garments such as waist-high stockings and abdominal binders have been shown to improve orthostatic hypotension in these patients. The purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing blood pressure and orthostatic tolerance in these patients, and to compare them with those of the standard of care midodrine. The investigators will test the hypothesis that abdominal compression will blunt the exaggerated fall in stroke volume and the increase in abdominal vascular volume during head up tilt. This study will help us better understand the contribution of the abdominal veins to orthostatic hypotension and the mechanisms underlying this non-pharmacological therapeutic approach.

Participants will be studied in a tilt table in two separate days in a randomized, crossover fashion with sham abdominal compression (~5 mmHg) and active compression (~40 mmHg).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female patients,

• between 18-80 yrs.,

• with neurogenic orthostatic hypotension associated with primary autonomic failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure). Orthostatic hypotension will be defined as =20 mmHg decrease in systolic BP or =10 mmHg of diastolic BP within 3 minutes on standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes (Freeman et al., 2011).

• Patients able and willing to provide informed consent.

Exclusion Criteria:

• Pregnancy.

• Significant cardiac, renal or hepatic illness, or with contraindications to administration of pressor agents or external abdominal compression will be excluded.

• 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

Related Conditions & MeSH terms

• Autonomic Failure
• Hypotension
• Hypotension, Orthostatic
• Multiple System Atrophy
• Orthostatic Hypotension
• Pure Autonomic Failure
• Shy-Drager Syndrome

Intervention

Other:
• Abdominal compression
Abdominal compression of 40 mmHg with a commercial inflatable cuff applied during head up tilt
• Sham abdominal compression
Sham abdominal compression of 5 mmHg with a commercial inflatable cuff applied during head up tilt

Drug:
• Placebo pill
Placebo pill given 1 hour before the second heat up tilt
• midodrine
Midodrine single dose 2.5-10mg PO given 1 hour before the second head up tilt

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke volume	Percent change from supine in stroke volume during head up tilt	an average of 15 minutes of head up tilt
Secondary	Systolic blood pressure	Change from baseline in systolic blood pressure during head up tilt	an average of 15 minutes of head up tilt
Secondary	Splanchnic vascular volume	Percent change from supine in splanchnic vascular volume during head up tilt.	an average of 15 minutes of head up tilt