Midodrine in Hepatopulmonary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-02

Study Completion Date

2020-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatopulmonary Syndrome (HPS)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label

All subjects enrolled will be assigned to receive midodrine. The initial starting dose will be midodrine 5mg orally three times a day. After 7-10 days, patients will increase the dose to 10mg three times a day as tolerated if no adverse effects occur. Treatment duration will be 6 months.

Group Type EXPERIMENTAL

Midodrine

Intervention Type DRUG

Midodrine is an oral alpha-1 agonist that increases vascular tone. It is administered orally. The initial starting dose will be midodrine 5mg orally three times a day. After 7-10 days, patients will increase the dose to 10mg three times a day as tolerated if no adverse effects occur. Treatment duration will be 6 months.

Interventions

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Midodrine

Midodrine is an oral alpha-1 agonist that increases vascular tone. It is administered orally. The initial starting dose will be midodrine 5mg orally three times a day. After 7-10 days, patients will increase the dose to 10mg three times a day as tolerated if no adverse effects occur. Treatment duration will be 6 months.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No