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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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:
Safety measures with special attention on symptomatic hypotension, arrhythmias, metabolic alkalosis and electrolyte disturbances will be addressed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VExUS guided decongestion | Diagnostic Test | Treatment team will be provided information about venous organ congestion status. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NT-ProBNP | Change in biomarker NT-ProBNP in serum. | From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days. |
| Change in estimated renal glomerular filtration rate |
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Inclusion Criteria:
Exclusion Criteria:
- Any medical or psychiatric condition which in the opinion of the investigatorprecludes participation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bård Waldum-Grevbo, MD, PhD | Contact | +4722119220 | uxwabr@ous-hf.no | |
| Liv M Jacobsen, MD | Contact | +4722119199 | uxjaiv@ous-hf.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology, Oslo University Hospital | Recruiting | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37813180 | Background | 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. | |
| 19215832 | Background | Damman 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. |
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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.
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Estimated glomerular filtration rate (eGFR) is calculated based on serum creatinine, age and gender.
| 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. | 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. | 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. | 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. | 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 | From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days. |
| 19215833 | Background | Mullens 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. |
| 32270297 | Background | Beaubien-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. |
| ID | Term |
|---|---|
| D059347 | Cardio-Renal Syndrome |
| D006333 | Heart Failure |
| D058186 | Acute Kidney Injury |
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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