RECRUITING

Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to learn more about the effects of midodrine and droxidopa, two medications used for the treatment of orthostatic hypotension (low blood pressure on standing), on the veins of the abdomen of patients with autonomic failure. The study will be conducted at Vanderbilt University Medical Center, and consists of 2 parts: a screening and 2 testing days. The total length of the study will be about 5 days. About 34 participants will be screened for the study.

Official Title

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

Quick Facts

Study Start:2016-09

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02897063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Bonnie K Black, RN

CONTACT

615-343-6862

autonomics@vumc.org

Luis E Okamoto, MD

CONTACT

615-936-6119

autonomics@vumc.org

Principal Investigator

Italo Biaggioni, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Study Locations (Sites)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Italo Biaggioni, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-09

Study Completion Date2024-12

Study Record Updates

Study Start Date2016-09

Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

midodrine
droxidopa
splanchnic circulation

Additional Relevant MeSH Terms

Autonomic Failure
Pure Autonomic Failure
Multiple System Atrophy
Parkinson Disease
Orthostatic Hypotension