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

Portal Hypertension Clinical Trial

— DPH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02975323
• Other study ID #: 20-2605/R&D/HEC/12
• Status: Recruiting
• Phase: Phase 3
• First received: November 22, 2016
• Last updated: December 2, 2016
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: December 2016
• Source: Aga Khan University
• Contact: Syed Hasnain A Shah, M.D.
• Phone: 00922134864676
• Email: hasnain.alishah[@]aku.edu
• Is FDA regulated: No
• Health authority: Pakistan: Drug Regulatory Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Portal Hypertension

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Aga Khan University,	Karachi	Sind

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .		6 hours	No