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

NCT ID: NCT02975323

Last Updated: 2016-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-12-31

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.

Conditions

Portal Hypertension

Keywords

hepatic venous pressure gradient; liver disease; US Doppler waveform; Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single

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

Group Type: EXPERIMENTAL

Carvedilol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

carveda

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Syed Hasnain Ali Shah

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aga Khan University,

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Syed Hasnain A Shah, M.D.

Role: CONTACT

Phone: 00922134864676

Email: hasnain.alishah@aku.edu

Facility Contacts

Tasneem Khan, MBA

Role: primary

Other Identifiers

20-2605/R&D/HEC/12

Identifier Type: -

Identifier Source: org_study_id