BRING-UP 3 Heart Failure

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06279988
• Lead Sponsor: Heart Care Foundation

Brief 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.

Study Timeline

• Study Start: 2023-09-15
• Status Verified: 2024-02
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2026-06-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of adherence to Guideline-Directed Medical Therapy (GDMTs) in HFrEF	6 months	To assess the rate of patients with HFrEF appropriately treated with the 4 therapeutic pillars \[Angiotensin Converting Enzyme Inhibitors (ACE-i)/Angiotensin Receptor Blockers (ARBs)/Angiotensin Receptor/Neprilysin Inhibitor (ARNI), betablockers, mineralocorticoid receptor antagonist (MRAs), Sodium-Glucose Co-Transporter-2 (SGLT2i)\] recommended by current European Society of Cardiology (ESC) 2021 guidelines. Patients with a documented contraindication to one or more of the 4 recommended therapeutic pillars will be included in the group of appropriately treated patients.

Secondary Outcome Measures

Name	Time	Method
Treatment patterns of patients with Acute Heart Failure (AHF) irrespective of the level of EF	6 months	To assess the rate of use of vasopressors, vasodilators, renal replacement therapy and mechanical circulatory support, pharmacological treatments and follow-up planning at discharge and to describe and assess the rate of adverse reactions reported by the Investigators when detected during their usual clinical practice.
All cause and specific causes of death and hospitalization (Exploratory endpoint)	12 months	To evaluate the rate of occurrence of clinical events during the 12 months follow-up of each enrolment phase. Specifically all-cause death, all-cause hospitalizations, specific causes of death and hospitalizations.
Rate of patient achieving appropriate dosages of GDMTs	6 months	to assess the rate of patients treated with appropriate dosages\* of:ACE-i/ARBs/ARNI, betablockers, MRAs, SGLT2i and to describe and assess the rate of adverse reactions reported by the Investigators when detected during their usual clinical practice; \*For the purpose of the present study appropriate dosage is defined as a dosage ≥50% of the maximal recommended dosage by the current guidelines
Treatment patterns of patients with Heart failure with mildly reduced ejection fraction (HFmrEF) and Heart failure with preserved ejection fraction (HFpEF)	6 months	To assess how novel treatment recommendations for HFmrEF and HFpEF are implemented in practice, specifically the rate of use of ARNI and SGLT2i and to describe and assess the rate of adverse reactions reported by the Investigators when detected during their usual clinical practice

Trial Locations

Locations (187)

Ospedale Santo Spirito - Sc Cardiologia; 🇮🇹 Casale Monferrato, AL, Italy

Ospedale San Giacomo - Sc Cardiologia; 🇮🇹 Novi Ligure, AL, Italy

Ospedali Riuniti - Sod Cardiologia Ospedaliera E Utic; 🇮🇹 Ancona, AN, Italy

Irccs Inrca - Uo Cardiologia/Utic/Telecardiologia; 🇮🇹 Ancona, AN, Italy

Ospedale San Donato - U.O.C Cardiologia; 🇮🇹 Arezzo, AR, Italy

Ospedale Valdichiana Santa Margherita - Uosd Cardiologia S.O. Cortona; 🇮🇹 Cortona, AR, Italy

Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti'; 🇮🇹 Avellino, AV, Italy

Ospedale Miulli - U.O.C. Cardiologia - Utic; 🇮🇹 Acquaviva Delle Fonti, BA, Italy

Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic; 🇮🇹 Altamura, BA, Italy

Ospedale San Paolo - Cardiologia-Utic; 🇮🇹 Bari, BA, Italy

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