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

NCT02975323 | Unknown Phase 3 DMC

• 1 other identifier: 20-2605/R&D/HEC/12
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (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 .

  6 hours

Study Arms (1)

Single

EXPERIMENTAL

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

Interventions

Carvedilol 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.

Also known as: carveda

Single

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead
• Dow University of Health Sciences: collaborator

Study Sites (1)

Aga Khan University,

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Hypertension, Portal; Liver Diseases; Fibrosis

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Syed Hasnain A Shah, M.D.

CONTACT

00922134864676; hasnain.alishah@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 29, 2016
• Study Start: December 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2018
• Last Updated: December 5, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)