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

Overview

About this study

The purpose of this study is to assess the safety and tolerability of midodrine in patients with Hepatopulmonary Syndrome (HPS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥ 18 years of age.
  • 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.

Exclusion Criteria:

  • Vulnerable study population, including imprisoned individuals.
  • Non-English speaking patients.
  • Participation in other investigational drug studies.
  • Taking any medication classified as an MAO inhibitor.
  • Taking the medication Linezolid.
  • Any of the following conditions:
    • Systolic blood pressure> 160mmHg or diastolic blood pressure > 100mmHg;
    • Heart rate <5 0bpm;
    • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hilary DuBrock, M.D.

Closed for enrollment

Contact information:

Jacqulyn Reiter

(507)538-2224

Reiter.Jacqulyn@mayo.edu

More information

Publications

Publications are currently not available