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Doppler Ultrasound Hepatic Vein Waveform as a Non-invasive Tool in the Assessment of Severity of Portal Hypertension (DPH)

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ClinicalTrials.gov Identifier: NCT02975323
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : December 5, 2016
Sponsor:
Collaborator:
Dow University of Health Sciences
Information provided by (Responsible Party):
Dr. Syed Hasnain Ali Shah, Aga Khan University

Brief Summary:
Portal hypertension is the result of an increased hepatic vascular resistance and portal inflow. The best established method to assess portal pressures is the determination of wedged hepatic venous pressure gradient (HVPG). Ultrasound Doppler technique is non-invasive in the assessment of portal hypertension as compared with invasive technique of measurement of the hepatic venous pressure gradient (HVPG). Hemodynamic measurements (BP and pulse recording) will be done and then patient will be given tablet Carvedilol 12.5 mg in a single dose and wait till the time that 20% reduction in heart rate from the baseline occurs. Haemodynamic measurements will be repeated to assess the acute response to beta-adrenoreceptor blocker agent. The change in the HWF will be recorded post beta-adrenoreceptor blocker administration.

Condition or disease Intervention/treatment Phase
Portal Hypertension Drug: Carvedilol Phase 3

Detailed Description:

Ultrasound Doppler technique is non-invasive in the assessment of portal hypertension as compared with invasive technique of measurement of the hepatic venous pressure gradient (HVPG). The Doppler waveform of the hepatic vein in healthy subjects is normally triphasic (two negative waves and one positive wave) because of central venous pressure variations due to the cardiac cycle. The normal triphasic hepatic vein waveform is transformed into a biphasic or monophasic waveform in patients with cirrhosis. A monophasic waveform has been shown to correlate with a high Child-Pugh score and a poor survival rate.

Therefore, Hepatic vein waveform (HVWF) evaluation with Doppler US may be used as a supplemental tool to assess the severity of Portal Hypertension and therapeutic response to portal pressure lowering drugs in primary prophylaxis of variceal bleed in patients with large oesophageal varices. There's one study which has looked into the same topic but it has been conducted on alcoholic cirrhotics.

Doppler ultrasound is a non-invasive tool in the measurement of portal pressure in portal hypertensive patients. Hemodynamic measurements (BP and pulse recording) will be done and then patient will be given tablet Carvedilol 12.5 mg in a single dose and wait till the time that 20% reduction in heart rate from the baseline occurs. Haemodynamic measurements will be repeated to assess the acute response to beta-adrenoreceptor blocker agent. The change in the HWF will be recorded post beta-adrenoreceptor blocker administration. This study will be a validation and interventional study. It is an open labeled study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Doppler Ultrasound Hepatic Vein Waveform as a Non-invasive Tool in the Assessment of Severity of Portal Hypertension (DPH Trial)
Study Start Date : December 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Single
To administer Carvedilol 12.5 mg orally and measure Wedge pressure gradient in hepatic veins followed by change in hepatic vein wave form
Drug: Carvedilol
Single dose of oral carvedilol 12.5 mg and wait till the time there's 20% reduction in hepatic wedge pressure gradient from the baseline.
Other Name: carveda




Primary Outcome Measures :
  1. Assessment of Correlation of HWF as detected on doppler ultrasound (tri-, bi,- monophasic pattern) and HVPG (mm Hg) as assessed at hepatic vein catherization in the portal hypertensive patient . [ Time Frame: 6 hours ]


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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with cirrhosis and large varices (≥ 5mm) on screening endoscopy
  • Not known esophageal or gastric variceal bleed

Exclusion Criteria:

  • Small esophageal varices (<5 mm in size) on screening endoscopy
  • Hemodynamically unstable i.e. Blood pressure of <90mmHg and tachycardia of >100bpm.
  • Contraindication to Beta-blockers (Asthma, bradycardia, heart failure, allergy)
  • history of Esophageal or gastric variceal bleed in the past
  • Hepatocellular carcinoma or other metastatic malignancy.
  • Portal vein thrombosis (PVT) or Inferior venacaval (IVC) thrombosis
  • Congestive cardiac failure (CCF)
  • Renal failure or Hepatorenal syndrome (Creatine of >1.5 mg/dl)
  • Previous allergy to IV contrast agent.
  • Lactating or Pregnant women

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): NCT02975323


Contacts
Contact: Syed Hasnain A Shah, M.D. 00922134864676 hasnain.alishah@aku.edu

Locations
Pakistan
Aga Khan University, Recruiting
Karachi, Sind, Pakistan, 74800
Contact: Tasneem Khan, MBA    00922134864670    tasneem.khan@aku.edu   
Sponsors and Collaborators
Aga Khan University
Dow University of Health Sciences

Responsible Party: Dr. Syed Hasnain Ali Shah, Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT02975323     History of Changes
Other Study ID Numbers: 20-2605/R&D/HEC/12
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Syed Hasnain Ali Shah, Aga Khan University:
hepatic venous pressure gradient
liver disease
US Doppler waveform
Cirrhosis

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists