Reduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• Main ID: NCT02726711
• Date of registration: 28/01/2016
• Prospective Registration: Yes
• Primary sponsor: Vanderbilt University
• Public title: Reduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic
• Scientific title: Reduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic Aim 1 of Rare Diseases Clinical Research Network (RDCRN) Project 2
• Date of first enrolment: April 2016
• Target sample size: 2
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02726711
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Italo Biaggioni, M.D.
• Affiliation: Vanderbilt University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female subjects, age 40-80 years, with possible or probable Multiple System
Atrophy, 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.

- Supine hypertension, defined as systolic blood pressure =150 mmHg measured on two
separate occasions.

- Subjects able and willing to provide informed consent.

Exclusion Criteria:

- 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 aneurysms, 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 intra-abdominal 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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple System Atrophy

Orthostatic Hypotension

Supine Hypertension

Intervention(s)

Drug: Placebo

Drug: Trimethaphan

Primary Outcome(s)

The percentage of increase of the y intercept of the P-V relationship [Time Frame: 5 years]

Secondary ID(s)

151947

Source(s) of Monetary Support

Please refer to primary and secondary sponsors