Longitudinal Validation of CIRC Technologies
NCT07081711
Aortic Diseases, Arrhythmias, Cardiac
Cleveland, Ohio, United States
View Trial DetailsNCT Number: NCT06279988
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ospedale Santo Spirito - Sc Cardiologia, Casale Monferrato, AL, Italy
Observational, prospective, multicenter study conducted in a large, representative sample of Italian cardiology centers.
Phases 1:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Diagnosis will be made by the local attending physician following the ESC guidelines recommendations.
Exclusion criteria
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Aldo P Maggioni, MD
CONTACT
055/5101361
Fabrizio G Oliva, MD
CONTACT
055/5101361
Heart Care Foundation
Other
Acronym: BRING-UP3HF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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