BRING-UP 3 Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeart Care Foundation
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old.
Males and females at birth.
Any ejection fraction level (level of ejection fraction measured in the 6 months preceding enrollment).
Ambulatory chronic HF or Hospitalized de-novo or worsening HF.
Disqualifiers
Active neoplasia or very severe disease compromising short-medium term life expectancy.
Participation in interventional studies.
Patients already enrolled into the study from another participating center or in the previous enrolling phase.
Trial population
All consecutive patients with chronic HF and those admitted for acute (de novo or worsening) HF.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Rate of adherence to Guideline-Directed Medical Therapy (GDMTs) in HFrEF
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.
Time frame
6 monthsSecondary outcomes
1
Rate of patient achieving appropriate dosages of GDMTs
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
Time frame
6 months2
Treatment patterns of patients with Heart failure with mildly reduced ejection fraction (HFmrEF) and Heart failure with preserved ejection fraction (HFpEF)
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
Time frame
6 months3
Treatment patterns of patients with Acute Heart Failure (AHF) irrespective of the level of EF
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.
Time frame
6 months4
All cause and specific causes of death and hospitalization (Exploratory endpoint)
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.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov