A Phase 1 interventional study of Midodrine in Hepatopulmonary Syndrome (HPS), sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-06.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment
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.
Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
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Moderate to very severe hepatopulmonary syndrome, defined as the presence of all of the following:
Exclusion Criteria:
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.
Drug: 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.
Safety and tolerability (adverse events (AEs))
Outcome will be defined by the incidence of adverse events (AEs) that occur during the study period. An adverse event is defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Abnormal results of diagnostic procedures are considered to be AEs if the abnormality results in study withdrawal, is associated with a serious AE, is associated with clinical signs or symptoms, leads to additional treatment or further diagnostic tests or is considered by the investigator to be of clinical significance. Each adverse event will be further characterized by severity and relationship to the study drug. Adverse event are classified as serious if they are: fatal, life-threatening, require or prolongs hospital stay, lead to persistent or significant disability or incapacity or a congenital anomaly or birth defect.
Time frame: 6 months
Arterial Oxygenation
Describe the effect of midodrine on: • arterial oxygenation (PaO2 and A-a gradient )(mmHg)
Time frame: 3 months and 6 months
Diffusion capacity
Describe the effect of midodrine on: • percent predicted diffusion capacity for carbon monoxide (Range 0-100%)
Time frame: 3 months and 6 months
Cardiac output
Describe the effect of midodrine on cardiac output (L/min) as estimated by echocardiogram in patients with HPS.
Time frame: 3 months and 6 months
Intrapulmonary shunting
Describe the effect of midodrine on severity (mild, moderate or severe) of intrapulmonary shunting (as assessed by echocardiogram shunt study) in patients with HPS.
Time frame: 3 months and 6 months
Intrapulmonary shunting
Describe the effect of midodrine on severity of intrapulmonary shunting (as assessed by percent shunt index (0-100%) on technetium macroaggregated albumin scan) in patients with HPS.
Time frame: 6 months
Symptoms as assessed by Modified Medical Research Council (MMRC)dyspnea scale
Describe the effect of midodrine on MMRC dyspnea scale (0-4). Higher numbers indicate more severe dyspnea.
Time frame: 3 months and 6 months
6 minute walk distance
Describe the effect of midodrine on 6 minute walk distance, in meters.
Time frame: 3 months and 6 months
Ran from Aug 2018 to primary completion in Dec 2020, 27 months.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midodrine
Hepatopulmonary Syndrome