Acute Heart FailureNCT06397404
VExUS in Patients With Acute Heart Failure
An observational study of Acute Heart Failure, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The importance of assessing venous congestion in heart failure patients is widely acknowledged, but its study is hampered by the lack of a practical evaluation tool. Venous excess ultrasound score (VExUS) is a promising noninvasive ultrasound-guided modality that can detect and objectify clinically significant organ… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Venous excess ultrasound score (VExUS) protocol
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 18 May 2023to 25 Dec 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study involved patients over 18 years of age admitted to the hospital with AHF and requiring intravenous administration of loop diuretics. Diagnosis was based on the European Society of Cardiology (ESC) HF guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) >1000 pg/ml.
Who may be able to join
- Acute decompensation of heart failure (diagnosis was based on the European Society of Cardiology (ESC) heart failure guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 1000 pg/ml
Who cannot join
- Chronic renal replacement therapy or glomerular filtration rate < 15 ml/min/1.73m 2 (chronic kidney disease Epidemiology Collaboration (CKD)-EPI)
- Cirrhosis with portal hypertension
- Acute myocardial infarction according to The Fourth Universal Definition of Myocardial infarction
- Pulmonary embolism
- Sepsis (according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))
- Endotracheal intubation at the time of admission
Show all 11Show fewer
- Pregnancy or breastfeeding
- Aortic dissection
- Active cancer
- Neurological or mental disease during exacerbation
- Refusal to sign an informed consent form, inadequate acoustic window
Trial locations and contacts
1 site in 1 country.
Russia1 site
City clinical hospital named after S. S. Yudin, Moscow City Health Department, Moscow, Russian Federation
Moscow, 115446
About this study
Official title: Congestion Assessment Using Venous Excess Ultrasound Score (VExUS) in Patients With Acute Heart Failure
The importance of assessing venous congestion in heart failure patients is widely acknowledged, but its study is hampered by the lack of a practical evaluation tool. Venous excess ultrasound score (VExUS) is a promising noninvasive ultrasound-guided modality that can detect and objectify clinically significant organ congestion. VExUS congestion grading score was still not formally validated in patients with AHF, as there is limited data on its clinical application in this group of patients.
Read the detailed description
It is currently unknown whether changes in systemic venous congestion, assessed by venous excess ultrasound score (VExUS), are associated with worsening renal function, reduced diuretic and natriuretic response, and poor prognosis in patients with acute decompensation of heart failure (AHF).
This prospective, observational, single-center study included patients admitted to the intensive care unit with AHF. At admission all patients undergo bedside Doppler ultrasound of inferior vena cava, hepatic, portal and renal veins to determine blood flow patterns. Congestion was graded with the VExUS score (grade 0, grade 1, grade 2, grade 3). Sodium concentration in a spot urine sample was assessed in 1 hour after first standard intravenous loop diuretic administration. The primary endpoint was the development of acute kidney injury (AKI), defined as oligoanuria (diuresis rate <0.5 ml/kg/hour for 6 hours) and an increase of serum creatinine >26 µmol/l within a 48-hour period or 50% from baseline creatinine within a week. The secondary endpoints were in-hospital mortality, change in spot urine sodium content <50 mmol/l and development of diuretics resistance (defined as the need to double starting dose of intravenous furosemide in 6 hours without adding a different class of diuretic agents).
- Conditions
- Acute Heart Failure
- Being tested
- Venous excess ultrasound score (VExUS) protocol
- Keywords
- Cardiorenal Syndrome, Acute Kidney Injury, Fluid Overload, VEXUS, Natriuresis, Diuretics resistance, Congestion, Intrarenal blood flow
- Medical subject headings
- Cardio-Renal Syndrome, Acute Kidney Injury, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous excess ultrasound score (VExUS) protocolDiagnostic test
All patients upon admission undergo ultrasound assessment of diameter and collapsibility of the inferior vena cava, hepatic vein Doppler, portal vein Doppler, intra-renal venous Doppler.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute decompensated heart failure | The study involved patients over 18 years of age admitted to the hospital with acute heart failure and requiring intravenous administration of loop diuretics. Diagnosis was based on the European Society of Cardiology (ESC) heart failure guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) >1000 pg/ml. Receives: Diagnostic Test: Venous excess ultrasound score (VExUS) protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of acute kidney injury (AKI)
Assessment of patient's serum creatinine at admission, in 48 hours, at day 7, and calculation of the amount of urine output in the first 6 h after the administration of a loop diuretic.
Measured: During 7 days of hospital stay
Secondary outcomes (3)
In-hospital mortality
Death from any cause, whichever came first
Measured: During patient's hospital stay (up to 14 days)
Change in spot urine sodium content <50 mmol/l
Sodium concentration in a spot urine sample is assessed in 1 hour after first intravenous loop diuretic administration. Reduction of natriuretic response in the face of congestion with volume overload with spot urine sodium content <50 mEq/L generally identifies a patient with an insufficient diuretic response.
Measured: 1 hour after first standard intravenous loop diuretic administration after patient's admission.
Development of diuretics resistance (defined as the need to double initial dose of intravenous furosemide in 6 hours without adding a different class of diuretic agents)
Assessment of diuretic response: patient's urine output (ml/kg/hour) in the first 6 hours and patient's medical record with doses of administered diuretics.
Measured: 6 hours after first intravenous furosemide administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start18 May 2023
- Primary completion25 Nov 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofia Sovetova, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397404
- Sponsor's protocol ID
- SS-DCFUD-02-2023
- Status last verified
- Mar 2024
- First submitted
- 6 Apr 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Local Ethics Committee policy
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congestion Assessment Using Venous Excess Ultrasound Score (VExUS) in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT06397404
- Acronym / sponsor ID
- SS-DCFUD-02-2023
- Conditions
- Acute Heart Failure
- Keywords
- Cardiorenal Syndrome, Acute Kidney Injury, Fluid Overload, VEXUS, Natriuresis, Diuretics resistance, Congestion, Intrarenal blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 2 May 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 importance of assessing venous congestion in heart failure patients is widely acknowledged, but its study is hampered by the lack of a practical evaluation tool. Venous excess ultrasound score (VExUS) is a promising noninvasive ultrasound-guided modality that can detect and objectify clinically significant organ congestion. VExUS congestion grading score was still not formally validated in patients with AHF, as there is limited data on its clinical application in this group of patients.
Detailed description
It is currently unknown whether changes in systemic venous congestion, assessed by venous excess ultrasound score (VExUS), are associated with worsening renal function, reduced diuretic and natriuretic response, and poor prognosis in patients with acute decompensation of heart failure (AHF).
This prospective, observational, single-center study included patients admitted to the intensive care unit with AHF. At admission all patients undergo bedside Doppler ultrasound of inferior vena cava, hepatic, portal and renal veins to determine blood flow patterns. Congestion was graded with the VExUS score (grade 0, grade 1, grade 2, grade 3). Sodium concentration in a spot urine sample was assessed in 1 hour after first standard intravenous loop diuretic administration. The primary endpoint was the development of acute kidney injury (AKI), defined as oligoanuria (diuresis rate <0.5 ml/kg/hour for 6 hours) and an increase of serum creatinine >26 µmol/l within a 48-hour period or 50% from baseline creatinine within a week. The secondary endpoints were in-hospital mortality, change in spot urine sodium content <50 mmol/l and development of diuretics resistance (defined as the need to double starting dose of intravenous furosemide in 6 hours without adding a different class of diuretic agents).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute decompensated heart failure | – | Diagnostic Test: Venous excess ultrasound score (VExUS) protocolThe study involved patients over 18 years of age admitted to the hospital with acute heart failure and requiring intravenous administration of loop diuretics. Diagnosis was based on the European Society of Cardiology (ESC) heart failure guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) >1000 pg/ml. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study involved patients over 18 years of age admitted to the hospital with AHF and requiring intravenous administration of loop diuretics. Diagnosis was based on the European Society of Cardiology (ESC) HF guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) >1000 pg/ml.
Key inclusion criteria (1 listed)
- Acute decompensation of heart failure (diagnosis was based on the European Society of Cardiology (ESC) heart failure guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 1000 pg/ml
Key exclusion criteria (11 listed)
- Chronic renal replacement therapy or glomerular filtration rate < 15 ml/min/1.73m 2 (chronic kidney disease Epidemiology Collaboration (CKD)-EPI)
- Cirrhosis with portal hypertension
- Acute myocardial infarction according to The Fourth Universal Definition of Myocardial infarction
- Pulmonary embolism
- Sepsis (according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))
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 |
|---|---|---|
| Venous excess ultrasound score (VExUS) protocolAll patients upon admission undergo ultrasound assessment of diameter and collapsibility of the inferior vena cava, hepatic vein Doppler, portal vein Doppler, intra-renal venous Doppler. | Diagnostic test | Patients with acute decompensated heart failure |
Primary outcome
Development of acute kidney injury (AKI)
Time frame: During 7 days of hospital stay
Assessment of patient's serum creatinine at admission, in 48 hours, at day 7, and calculation of the amount of urine output in the first 6 h after the administration of a loop diuretic.
3 secondary outcomes
In-hospital mortality
Time frame: During patient's hospital stay (up to 14 days)
Change in spot urine sodium content <50 mmol/l
Time frame: 1 hour after first standard intravenous loop diuretic administration after patient's admission.
Development of diuretics resistance (defined as the need to double initial dose of intravenous furosemide in 6 hours without adding a different class of diuretic agents)
Time frame: 6 hours after first intravenous furosemide administration
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 20 May 2024.
- ACC Middle East \& Eastern Mediterranean 2023, Athens, Greece, poster presentation. "Assessment of intrarenal venous flow can predict acute kidney injury in patients with acute heart failure." Sofia SovetovaLink provided by the sponsor.
- Sovetova, S, Andreev, D, Shchekochikhin, D. IMPACT OF RENAL BLOOD FLOW PATTERNS ON DIURETIC RESPONSE IN PATIENTS WITH ACUTE DECOMPENSATION OF HEART FAILURE. J Am Coll Cardiol. 2024 Apr, 83 (13\_Supplement) 335Link provided by the sponsor.
- Individual participant dataSharing planned: No. Local Ethics Committee policy
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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.
Sofia Sovetova principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 1 inclusion and 11 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 20 May 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 Russia. 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?
Development of acute kidney injury (AKI) (time frame: During 7 days of hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2024.