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

Primary Purpose

Portal Hypertension

Status
Unknown status
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Carvedilol
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Portal Hypertension focused on measuring hepatic venous pressure gradient, liver disease, US Doppler waveform, Cirrhosis

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aga Khan University,Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single

Arm Description

To administer Carvedilol 12.5 mg orally and measure Wedge pressure gradient in hepatic veins followed by change in hepatic vein wave form

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

Full Information

First Posted
November 22, 2016
Last Updated
December 2, 2016
Sponsor
Aga Khan University
Collaborators
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02975323
Brief Title
Doppler Ultrasound Hepatic Vein Waveform as a Non-invasive Tool in the Assessment of Severity of Portal Hypertension
Acronym
DPH
Official Title
Doppler Ultrasound Hepatic Vein Waveform as a Non-invasive Tool in the Assessment of Severity of Portal Hypertension (DPH Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
Dow University of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension
Keywords
hepatic venous pressure gradient, liver disease, US Doppler waveform, Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single
Arm Type
Experimental
Arm Description
To administer Carvedilol 12.5 mg orally and measure Wedge pressure gradient in hepatic veins followed by change in hepatic vein wave form
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
carveda
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Syed Hasnain A Shah, M.D.
Phone
00922134864676
Email
hasnain.alishah@aku.edu
Facility Information:
Facility Name
Aga Khan University,
City
Karachi
State/Province
Sind
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tasneem Khan, MBA
Phone
00922134864670
Email
tasneem.khan@aku.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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