Midodrine in Hepatopulmonary Syndrome

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Midodrine

Criteria

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