NCT06279988

BRING-UP 3 Heart Failure

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Heart Care Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this observational study is to assess the level of adherence to guideline recommendations regarding the management of patients with Heart Failure with Reduced Ejection Fraction (HFrEF); - the safety profile of the implementation of recommended treatments; - to monitor treatment patterns of patients with acute hert failure (HF); - to monitor treatment patterns of all patients with chronic HF irrespective of the level of ejection fraction (EF).

Detailed description

Observational, prospective, multicenter study conducted in a large, representative sample of Italian cardiology centers. Phases 1: 1. First educational intervention to discuss the recommendations of guidelines and treatment patterns in specific phenotypes of patients. 2. Data collection for 3 months or up to 30 consecutive patients with chronic HF or acute HF (both de novo and worsening). 3. Evaluation of the primary and secondary end-points of the study at 6 months after enrollment. Modifications of treatments will be monitored during the 6 months follow-up. 4. Second educational intervention to share the results of the first enrollment period of the study focusing the attention on existing gaps between guidelines recommendations and clinical practice. 5. New data collection for other 3 months or up to 30 consecutive patients with chronic HF or acute HF (both de novo and worsening). 6. Additional evaluation of the primary and secondary end-points of the study at 6 months after enrollment. Modifications of treatments will be monitored during the 6 months follow-up. 7. 12-month follow-up for all patients included in both enrolment phases of the study.

Conditions

• Heart Failure

Timeline

• Start date: 2023-09-15
• Primary completion: 2026-06-30
• Completion: 2026-07-30
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

187 sites across 1 country: Italy