NCT06714409 Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure
| NCT ID | NCT06714409 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Cardiorenal Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2024-09-16 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: \- Any medical or psychiatric condition which in the opinion of the investigatorprecludes participation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06714409 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiorenal Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06714409 currently recruiting?
Yes, NCT06714409 is actively recruiting participants. Contact the research team at uxwabr@ous-hf.no for enrollment information.
Where is the NCT06714409 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT06714409 clinical trial?
NCT06714409 is sponsored by Oslo University Hospital. The trial plans to enroll 180 participants.