Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)

Summary

Acute heart failure (AHF) is defined as rapid onset or rapid worsening of typical signs and symptoms of heart failure (HF) according to the 2016 European Society of Cardiology Guidelines. AHF is the first cause of hospitalization in people over 65 in Western countries, accounting for more than 1 million hospitalizations per year in the USA. This disease has many repercussions not only in terms of mortality and morbidity, but also in terms of resources and infrastructures necessary for these patients' treatment, which constitutes a high economic burden for the national health care system. Even with growing knowledge and means, nowadays, the prognosis of AHF is still poor and there are no proven therapies that lead to long-term benefits in terms of reduced mortality. A better management of the acute phase of decompensation, including the definition of effective diagnostic-therapeutic workup and the use of innovative drugs, could improve the course of the disease, with positive effects on the patient (gain in survival and reduction of admissions), but also on the community (containment of the overall health costs). In recent years, numerous scores have been outlined in various AHF settings, considering only a small number of parameters. Several prognostic models have been developed suggesting how difficult it is to evaluate the AHF patients' prognosis. All this effort towards the development of so numerous prognostic models is justified by the fact that, despite the evolution of treatments, the risk of re-hospitalization and of both intrahospital mortality and after discharge remains high. Several studies have investigated potential prognostic factors that could help evaluating the risk of cardiovascular events, but now there is no accurate and complete prognostic score, particularly for AHF patients. Therefore, to date there are no accurate scores or determinants of short- and medium-term prognosis that allow to improve the management of these patients. This will be an observational, prospective, multicentric, international, non-commercial (non-profit) study. The primary endpoint will be to evaluate the best parameters, among clinical, laboratory and echocardiographic variables assessed within 24 hours from the hospital admission and before discharge, that are able to predict rehospitalization for HF and cardiovascular death at 3 and 6 months, in patients admitted to the cardiology department for acute exacerbation of chronic HF or de novo AHF.

Conditions

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure With Mid Range Ejection Fraction
• Heart Failure With Reduced Ejection Fraction

Interventions

DIAGNOSTIC_TEST

Transthoracic Echocardiography

LV dimensions, LV mass and indices of LV function LA area and volume Indices of diastolic function (E/A ratio, E/e' ratio) Heart valve assessment according to GL RV dimensions and indices of RV function PAPs (RV-RA gradient and vena cava dimensions and collapsibility) B-lines at lung ultrasounds (comet lung score) Speckle Tracking analysis of LV (GLS), LA (PALS) and RV (LS of free wall) Optional 3D analysis of left and right ventricle

Sponsors & Collaborators

• European Association of Cardiovascular Imaging

  collaborator OTHER

• University of Siena

  lead OTHER

Principal Investigators

• Matteo Cameli, Prof · Department of Medical Biotechnologies Division of Cardiology University of Siena

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2022-07-31

Completion

2022-11-30

Countries

• Australia
• Belgium
• Greece
• Italy
• Mexico
• Netherlands
• North Macedonia
• Portugal
• Romania
• Spain
• Tunisia
• Turkey (Türkiye)

Study Locations