Midodrine in Hepatopumonary Syndrome



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:August 2, 2018
End Date:July 2, 2023
Contact:Adam Miller
Email:miller.adam@mayo.edu
Phone:507-266-8147

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A Phase 1 Proof-of-concept Clinical Trial Evaluating the Safety and Tolerability of Midodrine in Hepatopulmonary Syndrome

This proof-of-concept clinical trial will determine the safety and tolerability of midodrine
in patients with hepatopulmonary syndrome (HPS). Exploratory endpoints will assess the effect
of midodrine on oxygenation, intrapulmonary shunting and symptoms.


Inclusion Criteria:

- Moderate to very severe hepatopulmonary syndrome, defined as the presence of all of
the following:

1. Liver disease or portal hypertension

2. Intrapulmonary shunting on contrast-enhanced echocardiogram

3. Hypoxemia [A-a gradient ≥15mmHg (or ≥20mmHg if age >64) and PaO2<80mmHg on
arterial blood gas testing]

- Ability to provide informed consent

- Ability to comply with study medication use and testing, in the opinion of the
principal investigator or co-investigator

Exclusion Criteria:

- Vulnerable study population, including imprisoned individuals, non-English speaking
patients

- Participation in other investigational drug studies

- Any of the following conditions:

- Systolic blood pressure>160mmHg or diastolic blood pressure >100mmHg

- Heart rate <50bpm

- Urinary retention at baseline

- Left ventricular ejection fraction <50%

- Women who are pregnant, nursing, or who plan to become pregnant while in the trial

- Women of child-bearing potential not willing or able to use highly effective methods
of birth control
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Hilary M DuBrock
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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mi
from
Rochester, MN
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