VExUS in Patients With Acute Heart Failure

NCT06397404 | Completed

• 1 other identifier: SS-DCFUD-02-2023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Acute Heart Failure

Keywords

Cardiorenal Syndrome; Acute Kidney Injury; Fluid Overload; VEXUS; Natriuresis; Diuretics resistance; Congestion; Intrarenal blood flow

Outcome Measures

Primary Outcomes (1)

• 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.

  During 7 days of hospital stay

Secondary Outcomes (3)

• In-hospital mortality

  During patient's hospital stay (up to 14 days)

• Change in spot urine sodium content <50 mmol/l

  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)

  6 hours after first intravenous furosemide administration

Study Arms (1)

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.

Diagnostic Test: Venous excess ultrasound score (VExUS) protocol

Interventions

Venous excess ultrasound score (VExUS) protocol DIAGNOSTIC_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.

Patients with acute decompensated heart failure

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy or breastfeeding
• Aortic dissection
• Active cancer
• Neurological or mental disease during exacerbation
• Refusal to sign an informed consent form, inadequate acoustic window

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

City clinical hospital named after S. S. Yudin, Moscow City Health Department, Moscow, Russian Federation

Moscow, 115446, Russia

Location

Related Links

• 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 Sovetova
• 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) 335

MeSH Terms

Conditions

Cardio-Renal Syndrome; Acute Kidney Injury; Edema

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sofia Sovetova

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: May 2, 2024
• Study Start: May 18, 2023
• Primary Completion: November 25, 2023
• Study Completion: December 25, 2023
• Last Updated: May 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)