Clinical Trial

BIOmarker Based Diagnostic TOOLkit to Personalize Pharmacological Approaches in Congestive Heart Failure

Active, Not Recruiting
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Summary
This retrospective study will take advantage of an existing EU-funded dataset, the BIOlogy Study to TAilored Treatment in Chronic Heart Failure (BIOSTAT-CHF), which was designed to identify biomarkers related to the response to guideline directed medical therapy, and coordinated by UMCG. The availability of this comprehensive dataset of patients with severe HFrEF, prospectively and consistently collected, with the possibility to access a biobank to re-assay samples with novel biomarkers, provides a unique opportunity to derive preliminary data about the interaction between biomarkers of congestion and diuretic doses, that were prescribed based on clinical judgement, and therefore derive a machine learning-based algorithm than could be tested to guide the management of diuretic therapy
Protocol Amendment History 2 changes
notable Primary completion pushed: 2012-12 -> 2025-02-20 2026-05-08
minor Completion pushed: 2012-12 -> 2034-01-10 2026-05-08
Trial Details
NCT Number NCT07470554
Lead Sponsor IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions Heart Failure With Reduced Ejection Fraction (HFrEF), Congestive Heart Failure(CHF)
Enrollment 4,254 participants
Start Date 2024-12-10
Primary Completion 2025-02-20 (estimated)
Study Completion 2034-01-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-07