Cardiorenal SyndromeVExOUS-ADHFNCT06714409
Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure
A study testing VExUS guided decongestion in people with Cardiorenal Syndrome and Heart Failure, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to assess the feasibility, safety and effectiveness of VExUS guided organ decongestion compared to standard of care in patients hospitalized with acute decompensated heart failue (ADHF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiorenal Syndrome, Heart Failure, Acute Kidney Injury
- What is being tested?
- VExUS guided decongestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- 16 Sep 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or above
- Admitted the ward of Department of Cardiology OUH Ullevål with a clinical diagnosis of ADHFdefined by European Society of Cardiology
- Pro-BNP > 800 ng/l at first day of admission
- Capable of giving signed informed consent
Who cannot join
- Any medical or psychiatric condition which in the opinion of the investigatorprecludes participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Department of Nephrology, Oslo University Hospital
Oslo, 0424
Bård Waldum-Grevbo, MD, PhD, +4722119220, uxwabr@ous-hf.no
Liv M Jacobsen, MD, +4722119199, uxjaiv@ous-hf.no
About this study
Official title: A Parallel-group, Single-center, Two-arm Treatment Study to Assess the Safety and Effectiveness of Venous Ultrasound Guided Decongestion in Adult Patients Hospitalized with Acute Decompensated Heart Failure.
The purpose of this study is to assess the feasibility, safety and effectiveness of VExUS guided organ decongestion compared to standard of care in patients hospitalized with acute decompensated heart failue (ADHF).
180 patients will be randomly assigned to either intervention (VExUS) arm or standard of care (SOC) arm. In the intervention arm, the treatment team will be informed by the study team about the results of the VExUS examination to supplement the clinical decision of proper decongestion treatment, while no information will be provided in the standard of care arm. Study visits are scheduled every second day while hospitalized, end of study is set to day of discharge from the ward. Telephone consultation and review of medical journal scheduled after 6 months to assess exploratory endpoints.
Read more
The overall rationale of the the study is to investigate if venous organ congestion investigated by VExUS score, is a modifiable risk factor in patients hospitalized with ADHF. And secondary to assess if venous organ decongestion guided by VExUS score may safely be implemented in patients hospitalized with ADHF and result in:
- differences in length of hospitalization
- changes in biomarkers of cardiac strain
- changes in renal function and markers of renal injury
- achieved doses of heart failure treatment at discharge
- in-hospital complications
Safety measures with special attention on symptomatic hypotension, arrhythmias, metabolic alkalosis and electrolyte disturbances will be addressed.
- Conditions
- Cardiorenal Syndrome, Heart Failure, Acute Kidney Injury, Acute Decompensated Heart Failure
- Being tested
- VExUS guided decongestion
- Keywords
- Cardiorenal syndrome, Acute kidney injury, Heart failure, VExUS, Venous congestion
- Medical subject headings
- Cardio-Renal Syndrome, Heart Failure, Acute Kidney Injury, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VExUS guided decongestionDiagnostic test
Treatment team will be provided information about venous organ congestion status.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Patients in the intervention arm will undergo VExUS examinations at 1st day of inclusion, every other day while hospitalized and at discharge. The results from the VExUS examination (VExUS score) will be provided to the treatment team and the treatment team decides the individual treatment regime based on available information, with the overall goal to optimize decongestionand HF treatment according to current hospital standards. Safety issues and AEs will be assessed.In both gropus echocardiography will be performed at least once during the hospital stay. Receives: Diagnostic Test: VExUS guided decongestion |
| Standard of care | No intervention | Patients will undergo VExUS examinations at 1st day of inclusion and at discharge. The results from the VExUS examinations (VExUS score) will NOT be provided to the treatment team. They will be treated and followed up according to standard of care. In both gropus echocardiography will be performed at least once during the hospital stay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VExUS score
The findings from Doppler ultrasonography of the hepatic vein, portal vein, and interlobar renal vein will be graded using the VExUS score, which reflects the degree of venous congestion. The scale ranges from 0 to 3, where a score of 0 indicates no signs of congestion, 1 indicates mild congestion, 2 indicates moderate congestion, and 3 indicates severe congestion.
Measured: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Secondary outcomes (7)
Change in NT-ProBNP
Change in biomarker NT-ProBNP in serum.
Measured: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in estimated renal glomerular filtration rate
Estimated glomerular filtration rate (eGFR) is calculated based on serum creatinine, age and gender.
Measured: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in urine albumin creatinine ratio
Urine albumin creatinine is measured in spot urine sample.
Measured: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in symptoms
Participants are asked to grade their symptoms using a 7-point Likert scale ranging from 1 to 7, where 1 indicates markedly better, 4 indicates no change, and 7 indicates markedly worse. Additionally, participants are asked to report their general condition and level of dyspnea on a Visual Analogue Scale (VAS) where 0 is negative and 100 is positive.
Measured: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Length of hospitalization
Number of days from inclusion to discharge from hospital.
Measured: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Achieved dosage of HF medications at discharge
Current heart failure medication compared to target dose in the national recommendations of HF-patient population.
Measured: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Safety
Rates of symptomatic hypotension,worsening renal function, arrhythmias, severe metabolic alkalosis and electrolyte disturbances
Measured: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start16 Sep 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiorenal SyndromeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centre, parallel group, randomized controlled trail. Approximately 250 participants will be screened to achieve 90 randomly enrolled to study intervention and 90 participants to SOC arm for an estimated total of 180 evaluable participants.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Bård Waldum-Grevbo, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714409
- Sponsor's protocol ID
- 744207
- Acronym
- VExOUS-ADHF
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Longino A, Martin K, Leyba K, Siegel G, Thai TN, Riscinti M, Douglas IS, Gill E, Burke J. Prospective Evaluation of Venous Excess Ultrasound for Estimation of Venous Congestion. Chest. 2024 Mar;165(3):590-600. doi: 10.1016/j.chest.2023.09.029. Epub 2023 Oct 7.
PubMed 37813180Damman K, van Deursen VM, Navis G, Voors AA, van Veldhuisen DJ, Hillege HL. Increased central venous pressure is associated with impaired renal function and mortality in a broad spectrum of patients with cardiovascular disease. J Am Coll Cardiol. 2009 Feb 17;53(7):582-588. doi: 10.1016/j.jacc.2008.08.080.
PubMed 19215832Mullens W, Abrahams Z, Francis GS, Sokos G, Taylor DO, Starling RC, Young JB, Tang WHW. Importance of venous congestion for worsening of renal function in advanced decompensated heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):589-596. doi: 10.1016/j.jacc.2008.05.068.
PubMed 19215833Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w.
PubMed 32270297
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-group, Single-center, Two-arm Treatment Study to Assess the Safety and Effectiveness of Venous Ultrasound Guided Decongestion in Adult Patients Hospitalized with Acute Decompensated Heart Failure.
- ClinicalTrials.gov ID
- NCT06714409
- Acronym / sponsor ID
- VExOUS-ADHF / 744207
- Conditions
- Cardiorenal Syndrome, Heart Failure, Acute Kidney Injury, Acute Decompensated Heart Failure
- Keywords
- Cardiorenal syndrome, Acute kidney injury, Heart failure, VExUS, Venous congestion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 3 Dec 2024 (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.
The purpose of this study is to assess the feasibility, safety and effectiveness of VExUS guided organ decongestion compared to standard of care in patients hospitalized with acute decompensated heart failue (ADHF).
180 patients will be randomly assigned to either intervention (VExUS) arm or standard of care (SOC) arm. In the intervention arm, the treatment team will be informed by the study team about the results of the VExUS examination to supplement the clinical decision of proper decongestion treatment, while no information will be provided in the standard of care arm. Study visits are scheduled every second day while hospitalized, end of study is set to day of discharge from the ward. Telephone consultation and review of medical journal scheduled after 6 months to assess exploratory endpoints.
The overall rationale of the the study is to investigate if venous organ congestion investigated by VExUS score, is a modifiable risk factor in patients hospitalized with ADHF. And secondary to assess if venous organ decongestion guided by VExUS score may safely be implemented in patients hospitalized with ADHF and result in:
- differences in length of hospitalization
- changes in biomarkers of cardiac strain
- changes in renal function and markers of renal injury
- achieved doses of heart failure treatment at discharge
- in-hospital complications
Safety measures with special attention on symptomatic hypotension, arrhythmias, metabolic alkalosis and electrolyte disturbances will be addressed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single centre, parallel group, randomized controlled trail. Approximately 250 participants will be screened to achieve 90 randomly enrolled to study intervention and 90 participants to SOC arm for an estimated total of 180 evaluable participants.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Diagnostic Test: VExUS guided decongestionPatients in the intervention arm will undergo VExUS examinations at 1st day of inclusion, every other day while hospitalized and at discharge. The results from the VExUS examination (VExUS score) will be provided to the treatment team and the treatment team decides the individual treatment regime based on available information, with the overall goal to optimize decongestionand HF treatment according to current hospital standards. Safety issues and AEs will be assessed.In both gropus echocardiography will be performed at least once during the hospital stay. |
| Standard of care | No intervention | –Patients will undergo VExUS examinations at 1st day of inclusion and at discharge. The results from the VExUS examinations (VExUS score) will NOT be provided to the treatment team. They will be treated and followed up according to standard of care. In both gropus echocardiography will be performed at least once during the hospital stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or above
- Admitted the ward of Department of Cardiology OUH Ullevål with a clinical diagnosis of ADHFdefined by European Society of Cardiology
- Pro-BNP > 800 ng/l at first day of admission
- Capable of giving signed informed consent
Key exclusion criteria (1 listed)
- Any medical or psychiatric condition which in the opinion of the investigatorprecludes participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VExUS guided decongestionTreatment team will be provided information about venous organ congestion status. | Diagnostic test | Intervention arm |
Primary outcome
Change in VExUS score
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
The findings from Doppler ultrasonography of the hepatic vein, portal vein, and interlobar renal vein will be graded using the VExUS score, which reflects the degree of venous congestion. The scale ranges from 0 to 3, where a score of 0 indicates no signs of congestion, 1 indicates mild congestion, 2 indicates moderate congestion, and 3 indicates severe congestion.
7 secondary outcomes
Change in NT-ProBNP
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in estimated renal glomerular filtration rate
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in urine albumin creatinine ratio
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in symptoms
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Length of hospitalization
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Achieved dosage of HF medications at discharge
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Safety
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 37813180Longino A, Martin K, Leyba K, Siegel G, Thai TN, Riscinti M, Douglas IS, Gill E, Burke J. Prospective Evaluation of Venous Excess Ultrasound for Estimation of Venous Congestion. Chest. 2024 Mar;165(3):590-600. doi: 10.1016/j.chest.2023.09.029. Epub 2023 Oct 7.
- Background: PubMed 19215832Damman K, van Deursen VM, Navis G, Voors AA, van Veldhuisen DJ, Hillege HL. Increased central venous pressure is associated with impaired renal function and mortality in a broad spectrum of patients with cardiovascular disease. J Am Coll Cardiol. 2009 Feb 17;53(7):582-588. doi: 10.1016/j.jacc.2008.08.080.
- Background: PubMed 19215833Mullens W, Abrahams Z, Francis GS, Sokos G, Taylor DO, Starling RC, Young JB, Tang WHW. Importance of venous congestion for worsening of renal function in advanced decompensated heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):589-596. doi: 10.1016/j.jacc.2008.05.068.
- Background: PubMed 32270297Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VExUS guided decongestion in people with Cardiorenal Syndrome and Heart Failure, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bård Waldum-Grevbo, MD, PhD (+4722119220, uxwabr@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VExUS score (time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.). 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 NCT06714409, which also lists 4 linked publications.
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 3 Dec 2024.