- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02975323
Doppler Ultrasound Hepatic Vein Waveform as a Non-invasive Tool in the Assessment of Severity of Portal Hypertension (DPH)
Doppler Ultrasound Hepatic Vein Waveform as a Non-invasive Tool in the Assessment of Severity of Portal Hypertension (DPH Trial)
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Syed Hasnain A Shah, M.D.
- Phone Number: 00922134864676
- Email: hasnain.alishah@aku.edu
Study Locations
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Sind
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Karachi, Sind, Pakistan, 74800
- Recruiting
- Aga Khan University,
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Contact:
- Tasneem Khan, MBA
- Phone Number: 00922134864670
- Email: tasneem.khan@aku.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single
To administer Carvedilol 12.5 mg orally and measure Wedge pressure gradient in hepatic veins followed by change in hepatic vein wave form
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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6 hours
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Liver Diseases
- Hypertension
- Hypertension, Portal
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Protective Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Antioxidants
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Carvedilol
Other Study ID Numbers
- 20-2605/R&D/HEC/12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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