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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2024
• Main ID: NCT02429557
• Date of registration: 21/04/2015
• Prospective Registration: No
• Primary sponsor: Vanderbilt University Medical Center
• Public title: Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
• Scientific title: Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
• Date of first enrolment: April 2015
• Target sample size: 29
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02429557
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Bonnie K Black, RN

• Name: Italo Biaggioni, MD
• Affiliation: Vanderbilt University

• Name: Emily C Smith, RN

• Name: Luis E Okamoto, MD
• Affiliation: Vanderbilt University Medical Center

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Autonomic Failure

Multiple System Atrophy

Orthostatic Hypotension

Pure Autonomic Failure

Intervention(s)

Other: Abdominal compression

Other: Sham abdominal compression

Drug: Placebo pill

Drug: midodrine

Primary Outcome(s)

Stroke volume [Time Frame: an average of 15 minutes of head up tilt]

Secondary Outcome(s)

Splanchnic vascular volume [Time Frame: an average of 15 minutes of head up tilt]

Systolic blood pressure [Time Frame: an average of 15 minutes of head up tilt]

Secondary ID(s)

1R01HL144568-01A1

140634

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)