Doppler Ultrasound Hepatic Vein Waveform as a Non-invasive Tool in the Assessment of Severity of Portal Hypertension (DPH)
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|ClinicalTrials.gov Identifier: NCT02975323|
Recruitment Status : Unknown
Verified December 2016 by Dr. Syed Hasnain Ali Shah, Aga Khan University.
Recruitment status was: Recruiting
First Posted : November 29, 2016
Last Update Posted : December 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Portal Hypertension||Drug: Carvedilol||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Doppler Ultrasound Hepatic Vein Waveform as a Non-invasive Tool in the Assessment of Severity of Portal Hypertension (DPH Trial)|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2018|
To administer Carvedilol 12.5 mg orally and measure Wedge pressure gradient in hepatic veins followed by change in hepatic vein wave form
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 Name: carveda
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975323
|Contact: Syed Hasnain A Shah, M.D.||firstname.lastname@example.org|
|Aga Khan University,||Recruiting|
|Karachi, Sind, Pakistan, 74800|
|Contact: Tasneem Khan, MBA 00922134864670 email@example.com|