Midodrine in Hepatopulmonary Syndrome

Completed · Phase 1

Conditions studied: Hepatopulmonary Syndrome (HPS)

In brief

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.

Key facts

Study ID

NCT03600870

Run by

Mayo Clinic

People needed

10

Starts

2018-08-02

Expected to finish

2020-12-01

Last updated by the study team

2021-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to very severe hepatopulmonary syndrome, defined as the presence of all of the following:
• Liver disease or portal hypertension
• Intrapulmonary shunting on contrast-enhanced echocardiogram
• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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