Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 5/4/2018 |
| Start Date: | April 2015 |
| End Date: | March 2019 |
| Contact: | Flemming Forsberg, PhD |
| Email: | flemming.forsberg@jefferson.edu |
| Phone: | 215-955-4870 |
This is an open-label, non-randomized trial that will be conducted at two clinical sites,
Thomas Jefferson University (TJU) and the Hospital of the University of Pennsylvania (HUP).
Enrolled patients undergoing trans-jugular liver biopsy with hepatic vein pressure gradient
(HVPG) measurements will receive a continuous infusion of Sonazoid® (GE Healthcare, Oslo,
Norway) co-infused with 0.9% NaCl solution over a 5-10 minute time period. Ultrasound imaging
will be performed using a Logiq 9 scanner with a 4C transducer (GE Healthcare, Milwaukee, WI)
and the novel SHAPE (subharmonic aided pressure estimation) algorithm will be used to measure
pressure values in the hepatic and portal veins. Data will be stored on a PC and compared to
pressure-catheter measurements, Subjects identified in the initial examination as having
portal hypertension (by HVPG results) will be monitored by SHAPE for up to 18 months. These
subjects typically have surveillance Computed tomography (CT) or magnetic resonance imaging
(MRI) scans every 6 months to screen for liver cancer, and at those times a repeat SHAPE
examination will be performed (ideally within 1 month of their clinically indicated imaging
follow up appointment). In patients who undergo more frequent screening (generally 3 month
intervals), SHAPE exams will be performed at 6 month intervals. Any repeat trans-jugular
liver biopsies performed in this population will also trigger a repeat SHAPE study. Results
of blood test evaluations (performed every 3 months in this population), medication,
concomitant imaging study or procedure (including endoscopies) will be noted (all blood tests
and imaging are clinically indicated only and are not required by this protocol). The end
point for this part of the study will be any one new complication (e.g., liver cancer) or a
marked worsening in any complication, liver transplantation, death, or the end of this
clinical trial (after 3 years). The investigators expect these patients will be monitored
three times during the course of this clinical trial. The time to reach the end point will be
noted if a new complication or a marked worsening in any complication occurs.
Thomas Jefferson University (TJU) and the Hospital of the University of Pennsylvania (HUP).
Enrolled patients undergoing trans-jugular liver biopsy with hepatic vein pressure gradient
(HVPG) measurements will receive a continuous infusion of Sonazoid® (GE Healthcare, Oslo,
Norway) co-infused with 0.9% NaCl solution over a 5-10 minute time period. Ultrasound imaging
will be performed using a Logiq 9 scanner with a 4C transducer (GE Healthcare, Milwaukee, WI)
and the novel SHAPE (subharmonic aided pressure estimation) algorithm will be used to measure
pressure values in the hepatic and portal veins. Data will be stored on a PC and compared to
pressure-catheter measurements, Subjects identified in the initial examination as having
portal hypertension (by HVPG results) will be monitored by SHAPE for up to 18 months. These
subjects typically have surveillance Computed tomography (CT) or magnetic resonance imaging
(MRI) scans every 6 months to screen for liver cancer, and at those times a repeat SHAPE
examination will be performed (ideally within 1 month of their clinically indicated imaging
follow up appointment). In patients who undergo more frequent screening (generally 3 month
intervals), SHAPE exams will be performed at 6 month intervals. Any repeat trans-jugular
liver biopsies performed in this population will also trigger a repeat SHAPE study. Results
of blood test evaluations (performed every 3 months in this population), medication,
concomitant imaging study or procedure (including endoscopies) will be noted (all blood tests
and imaging are clinically indicated only and are not required by this protocol). The end
point for this part of the study will be any one new complication (e.g., liver cancer) or a
marked worsening in any complication, liver transplantation, death, or the end of this
clinical trial (after 3 years). The investigators expect these patients will be monitored
three times during the course of this clinical trial. The time to reach the end point will be
noted if a new complication or a marked worsening in any complication occurs.
Inclusion Criteria:
- Be scheduled for trans-jugular liver biopsy the day of the ultrasound procedure.
- Be at least 21 years of age.
- Be medically stable.
- If a female of child-bearing potential, must have a negative pregnancy test.
- Be conscious and able to comply with study procedures.
- Have read and signed the IRB-approved Informed Consent form for participating in the
study.
Exclusion Criteria:
- Females who are pregnant or nursing.
- Patients not scheduled for trans-jugular liver biopsy
- Patients who have received an investigational drug in the 30 days before study drug
administration, or will receive one within 72 h afterwards,.
- Patients with known or suspected right-to-left, bi-directional, or transient
right-to-left cardiac shunts
- Patients with pulmonary hypertension or unstable cardiopulmonary conditions
- Patients currently on chemotherapy or with other primary cancers requiring systemic or
hepatic loco-regional treatment.
- Patients who are medically unstable, patients who are seriously or terminally ill, and
patients whose clinical course is unpredictable. For example:
- Patients on life support or in a critical care unit.
- Patients with unstable occlusive disease (e.g., crescendo angina)
- Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular
tachycardia.
- Patients with uncontrolled congestive heart failure (NYHA Class IV)
- Patients with recent cerebral hemorrhage.
- Patients who have undergone surgery within 24 hours prior to the study sonographic
examination.
- Patients with a history of anaphylactic allergy to eggs or egg products, manifested by
one or more of the following symptoms: generalized urticaria, difficulty in breathing,
swelling of the mouth and throat, hypotension, or shock. (Subjects with
nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but
must be watched carefully for 1 h following the administration of SONAZOID).
- Patients with congenital heart defects.
- Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary
emboli.
- Patients with respiratory distress syndrome
- Patients with thrombosis within the hepatic, portal, or mesenteric veins.
We found this trial at
2
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Michael Soulen, MD
Phone: 215-615-3591
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Philadelphia, Pennsylvania 19107
Principal Investigator: Flemming Forsberg, PhD
Phone: 215-955-4870
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