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

Phase 3

• Conditions: Portal Hypertension
• Interventions: Drug: Carvedilol

• Registration Number: NCT02975323
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05
• Primary Completion: 2017-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aga Khan University,; 🇵🇰 Karachi, Sind, Pakistan