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BRING-UP 3 Heart Failure

BRING-UP 3 Heart Failure

Recruiting
18 years and older
All
Phase N/A

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Overview

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).

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.

Eligibility

Inclusion Criteria:

  1. Age ≥18 years old.
  2. Males and females at birth.
  3. Any ejection fraction level (level of ejection fraction measured in the 6 months preceding enrollment).
  4. Ambulatory chronic HF or Hospitalized de-novo or worsening HF.
  5. Signed informed consent
        Diagnosis will be made by the local attending physician following the ESC guidelines
        recommendations.
        Exclusion Criteria:
          1. Active neoplasia or very severe disease compromising short-medium term life
             expectancy.
          2. Participation in interventional studies.
          3. Patients already enrolled into the study from another participating center or in the
             previous enrolling phase.

Study details
    Heart Failure

NCT06279988

Heart Care Foundation

8 March 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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