Hepato-Renal SyndromeNCT03483272
MRI to Assess the Effect of Terlipressin in Patients With Acute Hepatorenal Syndrome (HRS-AKI)
An observational study of Hepato-Renal Syndrome and Portal Hypertension, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial summary
Heptorenal syndrome (HRS) is divided into two types. A non-acute kidney injury (NAKI-HRS), which is predominantly related to end-stage disease and a more acute kidney injury (HRS-AKI). Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Hepato-Renal Syndrome, Portal Hypertension, Acute Kidney Injury
- How many people
- 11 participants
- Where
- 2 sitesDenmark
- Study dates
- 8 Jan 2018to 21 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients with cirrhosis and acute kidney injury who meet the criteria for HRS-AKI and needs terlipressin treatment.
Who may be able to join
- Patients with cirrhosis and acute hepatorenal syndrome (HRS-AKI)
- Patient of more than 18 and less than 78 years of age
Who cannot join
- Patients who are unable to give informed consent
- Patients with absolute contraindication for MRI
- Patients with absolute contraindication for terlipressin
- Pregnant women
- Patient with severe hemodynamic comorbidity
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hvidovre University Hospital
Hvidovre, Capital Region, 2650
Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital
Hvidovre, 2650
About this study
Official title: MR-flow to Validate Hemodynamic Effect of Terlipressin in Patients With Acute Hepatorenal Syndrome: Can MRI and Echocardiography Predict the Pharmacological Response and Longterm Effect of Terlipressin?
Heptorenal syndrome (HRS) is divided into two types. A non-acute kidney injury (NAKI-HRS), which is predominantly related to end-stage disease and a more acute kidney injury (HRS-AKI). HRS-AKI is potentially reversible and develops subsequent to aggravation of a systemic circulatory vasodilatation, that triggers renal vasoconstriction and deteriorates renal perfusion and function. The albumin and terlipressin response is evaluated clinically, routinely for a week and reduces mortality with 23% compared to no treatment. Only 40-50% of the patients with HRS-AKI respond to the treatment with terlipressin.
The treatment of hepatorenal syndrome (HRS-AKI) is aimed at improving blood flow to the kidneys. Flow changes associated to development of HRS have only sparsely been studied and not previously by MR technique and no previous studies have evaluated changes in flow induced by terlipressin. It has been hypothesized that development of HRS is associated to a deterioration in heart function with development of cardiomyopathy, which together with renal vasoconstriction leads to renal failure. Simultaneous MR-assessments of cardiac function and flows (especially the renal flow) in HRS-AKI have not previously been performed.
Read more
The aim of the project is to develop new, fast and non-invasive methods to evaluate hemodynamic changes and individual pharmacological terlipressin response in patients with acute hepatorenal syndrome (type HRS-AKI)
We expect a higher increase in renal blood flow in terlipressin-responders compared to terlipressin-non-responders and non-responders will generally have a lower basic renal flow and a decreased cardiac output.
Study design and patients The study design is experimental and includes 30 cirrhotic patients with HRS-AKI. Patients with HRS-AKI are MR scanned before and 17 minutes after their first dose of terlipressin. ECHO is performed before first dose of Terlipressin and is repeated after one of the first doses of terlipressin. Clinically efficacy is defined in accordance to international guidelines at day-7 and 90 days mortality is registered. The screening period and treatments follow international and national guidelines for acute renal failure in patients with cirrhosis.
- Conditions
- Hepato-Renal Syndrome, Portal Hypertension, Acute Kidney Injury, Liver Diseases, Liver Cirrhoses, Cirrhosis Cardiac
- Keywords
- Terlipressin, Pharmacological respons, Magnetic Resonance Imaging, Hemodynamic assessments, Echocardiography, Hepatorenal syndrome - acute kidney injury
- Medical subject headings
- Hepatorenal Syndrome, Hypertension, Portal, Acute Kidney Injury, Liver Diseases, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow (mL/min) in kidney and splanchnic vessels in patients with HRS-AKI and cirrhotic patients without kidney impairment
- To characterize and compare changes in flow with MR and ECHO in patients with HRS-AKI compared to cirrhotic patients without kidney impairment
Measured: Baseline (mL/min)
Secondary outcomes (2)
Flow changes (mL/min) in HRS-AKI patients with terlipressin non-response vs. response.
To investigate whether flow changes measured with MR and echocardiography induced by a single dose of terlipressin can predict the clinical (7 days) response to terlipressin treatment.
Full terlipressin response is if creatinine level returns to baseline after 7 days treatment.
Partial response is a reduction in creatinine of 25% after 7 days terlipressin treatment
Measured: Response after 7 days treatment (mL/min)
Flow changes (mL/min) after terlipressin administration compared to mortality.
To investigate whether flow changes measured with MR and echocardiography induced by a single dose of terlipressin can predict the mortality after 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start8 Jan 2018
- Primary completion15 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepato-Renal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flemming Bendtsen, Hvidovre University Hospital
- Investigators
- Flemming Bendtsen, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483272
- Sponsor's protocol ID
- 17001401
- Status last verified
- Aug 2021
- First submitted
- 14 Mar 2018
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Danielsen KV, Hove JD, Nabilou P, Kronborg TM, Wiese S, Siebner HR, Scott R, Francis ST, Aithal GP, Moller S, Bendtsen F. Mapping the hemodynamic effects of terlipressin in patients with hepatorenal syndrome using advanced magnetic resonance imaging. JHEP Rep. 2025 May 10;7(8):101452. doi: 10.1016/j.jhepr.2025.101452. eCollection 2025 Aug.
PubMed 40677691
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-flow to Validate Hemodynamic Effect of Terlipressin in Patients With Acute Hepatorenal Syndrome: Can MRI and Echocardiography Predict the Pharmacological Response and Longterm Effect of Terlipressin?
- ClinicalTrials.gov ID
- NCT03483272
- Acronym / sponsor ID
- 17001401
- Conditions
- Hepato-Renal Syndrome, Portal Hypertension, Acute Kidney Injury, Liver Diseases, Liver Cirrhoses, Cirrhosis Cardiac
- Keywords
- Terlipressin, Pharmacological respons, Magnetic Resonance Imaging, Hemodynamic assessments, Echocardiography, Hepatorenal syndrome - acute kidney injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heptorenal syndrome (HRS) is divided into two types. A non-acute kidney injury (NAKI-HRS), which is predominantly related to end-stage disease and a more acute kidney injury (HRS-AKI). HRS-AKI is potentially reversible and develops subsequent to aggravation of a systemic circulatory vasodilatation, that triggers renal vasoconstriction and deteriorates renal perfusion and function. The albumin and terlipressin response is evaluated clinically, routinely for a week and reduces mortality with 23% compared to no treatment. Only 40-50% of the patients with HRS-AKI respond to the treatment with terlipressin.
The treatment of hepatorenal syndrome (HRS-AKI) is aimed at improving blood flow to the kidneys. Flow changes associated to development of HRS have only sparsely been studied and not previously by MR technique and no previous studies have evaluated changes in flow induced by terlipressin. It has been hypothesized that development of HRS is associated to a deterioration in heart function with development of cardiomyopathy, which together with renal vasoconstriction leads to renal failure. Simultaneous MR-assessments of cardiac function and flows (especially the renal flow) in HRS-AKI have not previously been performed.
The aim of the project is to develop new, fast and non-invasive methods to evaluate hemodynamic changes and individual pharmacological terlipressin response in patients with acute hepatorenal syndrome (type HRS-AKI)
We expect a higher increase in renal blood flow in terlipressin-responders compared to terlipressin-non-responders and non-responders will generally have a lower basic renal flow and a decreased cardiac output.
Study design and patients The study design is experimental and includes 30 cirrhotic patients with HRS-AKI. Patients with HRS-AKI are MR scanned before and 17 minutes after their first dose of terlipressin. ECHO is performed before first dose of Terlipressin and is repeated after one of the first doses of terlipressin. Clinically efficacy is defined in accordance to international guidelines at day-7 and 90 days mortality is registered. The screening period and treatments follow international and national guidelines for acute renal failure in patients with cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with cirrhosis and acute kidney injury who meet the criteria for HRS-AKI and needs terlipressin treatment.
Key inclusion criteria (2 listed)
- Patients with cirrhosis and acute hepatorenal syndrome (HRS-AKI)
- Patient of more than 18 and less than 78 years of age
Key exclusion criteria (5 listed)
- Patients who are unable to give informed consent
- Patients with absolute contraindication for MRI
- Patients with absolute contraindication for terlipressin
- Pregnant women
- Patient with severe hemodynamic comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Flow (mL/min) in kidney and splanchnic vessels in patients with HRS-AKI and cirrhotic patients without kidney impairment
Time frame: Baseline (mL/min)
i) To characterize and compare changes in flow with MR and ECHO in patients with HRS-AKI compared to cirrhotic patients without kidney impairment
2 secondary outcomes
Flow changes (mL/min) in HRS-AKI patients with terlipressin non-response vs. response.
Time frame: Response after 7 days treatment (mL/min)
Flow changes (mL/min) after terlipressin administration compared to mortality.
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Derived from this study: PubMed 40677691Danielsen KV, Hove JD, Nabilou P, Kronborg TM, Wiese S, Siebner HR, Scott R, Francis ST, Aithal GP, Moller S, Bendtsen F. Mapping the hemodynamic effects of terlipressin in patients with hepatorenal syndrome using advanced magnetic resonance imaging. JHEP Rep. 2025 May 10;7(8):101452. doi: 10.1016/j.jhepr.2025.101452. eCollection 2025 Aug.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flemming Bendtsen study chair
Hvidovre University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepato-Renal Syndrome and Portal Hypertension, run by Hvidovre University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow (mL/min) in kidney and splanchnic vessels in patients with HRS-AKI and cirrhotic patients without kidney impairment (time frame: Baseline (mL/min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03483272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.