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Effect of Midodrine on HVPG in Advanced Chronic Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04455464
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:
  • Primary objective: HVPG response after administration of midodrine as defined by decrease in HVPG by > 20 % from baseline or to less than equals to 12 mmHg.
  • Secondary objectives: Change in HVPG, SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean).

Methodology:

Consecutive patients of chronic liver disease in the Institute (admitted or coming to OPD) as per the inclusion and exclusion criteria will be studied.

  • Study Population: Patients of advanced chronic liver disease admitted or OPD patients in ILBS
  • Study Design: A single arm interventional study
  • Study Period: 6 months
  • Inclusion Criteria: i) CLD with grade III ascites with Na < 130 / Systolic BP < 90 / type 2 HRS(n=30 ) (ii) ACLF (APASL criteria) with Na < 130 / Systolic BP < 90 / AKI (n=30)
  • Exclusion Criteria: age < 18 and > 75, pregnancy, splanchnic venous thrombosis, HCC, HE, significant cardiopulmonary disease, uncontrolled diabetes, hypertension, intrinsic renal disease, peripheral vascular disease.
  • Sample Size with justification: This is a pilot study where a total of 60 patients will be enrolled - 30 each in the two groups.
  • Intervention: HVPG will be done in these patients at baseline and then after 3 hours of 10 mg of midodrine tablets.

Monitoring and assessment: Various parameters will be assessed during the procedure before and after 3 hours of midodrine such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2.

- Statistical Analysis: Continuous data will be represented by mean ± SD or median ± IQR. Categorical data will be represented by n = frequency (%). Categorical data will be analyzed by Chi square test or Fisher exact test as appropriate. Continuous data will be compared by using student t test or Mann Whitney test (when applicable). The change in HVPG will be analyzed by using paired t test or Wilcoxon signed rank test. The % change in the individual group will be compared to see the significance between the groups. The significance will be seen at 5%.

  • Adverse Effects: same as for HVPG (mild pain / hematoma at the puncture site, transient arrhythmias). Midodrine has got good safety profile and is used in patients of advanced chronic liver disease.
  • Stopping Rule of study: nil

Expected outcome of the project: If result shows that HVPG is decreased by midodrine, then it can be used in place of beta blockers when they are contraindicated or have the potential of causing adverse effects.


Condition or disease Intervention/treatment Phase
Chronic Liver Disease Drug: Midodrine Oral Tablet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Midodrine on HVPG in Advanced Chronic Liver Disease - A Pilot Study
Actual Study Start Date : July 11, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
Experimental: Midodrine
Midodrine will be given 10 mg for one time only. HVPG will be done at baseline and after 3 hours
Drug: Midodrine Oral Tablet
Midodrine will be given 10 mg for one time only.




Primary Outcome Measures :
  1. HVPG response after administration of midodrine as defined by decrease in HVPG by > 20 % from baseline or to less than equals to 12 mmHg [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Change in Hepatic Venous Pressure Gradient. [ Time Frame: 3 hours ]
  2. Change in Systemic Vascular Resistance. [ Time Frame: 3 hours ]
  3. Change in Heart Rate. [ Time Frame: 3 hours ]
  4. Change in Cardiac Output. [ Time Frame: 3 hours ]
  5. Change in Blood pressure (Systolic, Diastolic and Mean). [ Time Frame: 3 hours ]
  6. Change in Cardiac Index. [ Time Frame: 3 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- i) CLD with grade III ascites with Na < 130 / Systolic BP < 90 / type 2 HRS(n=30 ) ii) ACLF (APASL criteria) with Na < 130 / Systolic BP < 90 / AKI (n=30)

Exclusion Criteria:

  1. age < 18 and > 75,
  2. Pregnancy,
  3. Splanchnic venous thrombosis,
  4. Hepatocellular Carcinoma,
  5. Hepaticencephalopathy,
  6. Significant cardiopulmonary disease,
  7. Uncontrolled diabetes,
  8. Hypertension,
  9. Intrinsic renal disease,
  10. Peripheral vascular disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455464


Contacts
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Contact: Dr Chitranshu Vashishtha, DM 01146300000 chitranshuv@gmail.com
Contact: Dr Ankit Bhardwaj, Masters-CT bhardwaj.ankit3@gmail.com

Locations
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India
Institute of Liver & Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Chitranshu Vashishtha, DM    01146300000    chitranshuv@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT04455464    
Other Study ID Numbers: ILBS-Cirrhosis-33
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action