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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05204238




Registration number
NCT05204238
Ethics application status
Date submitted
10/01/2022
Date registered
24/01/2022
Date last updated
30/08/2022

Titles & IDs
Public title
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
Scientific title
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
Secondary ID [1] 0 0
FUTURE_1.4
Universal Trial Number (UTN)
Trial acronym
FUTURE-HIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Heart Failure With Preserved Ejection Fraction 0 0
Heart Failure With Mid Range Ejection Fraction 0 0
Heart Failure With Reduced Ejection Fraction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Transthoracic Echocardiography

Diagnosis / Prognosis: 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
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
predictors of rehospitalization for heart failure and cardiovascular death
Timepoint [1] 0 0
3 and 6 months post discharge
Secondary outcome [1] 0 0
combined prognostic score of rehospitalization for heart failure and cardiovascular death
Timepoint [1] 0 0
3 and 6 months post discharge
Secondary outcome [2] 0 0
Event analysis according to heart failure's different classes (HFpEF, HFmrEF, HFrEF)
Timepoint [2] 0 0
3 and 6 months post discharge
Secondary outcome [3] 0 0
Event analysis according to genres
Timepoint [3] 0 0
3 and 6 months post discharge

Eligibility
Key inclusion criteria
- age =18 years

- admission to the cardiology departments for acute heart failure (de novo or
exacerbation of chronic heart fail-ure) according to the clinical and instrumental
criteria in the current ESC guidelines

- signing of the informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- age < 18 years

- valve prosthesis

- previous heart transplant or LVAD

- poor acoustic window.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
Accrual to date
Final
998
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Blacktown Hospital, Faculty of Medicine, University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Edegem
Country [2] 0 0
Greece
State/province [2] 0 0
Athens
Country [3] 0 0
Greece
State/province [3] 0 0
Elefsína
Country [4] 0 0
Greece
State/province [4] 0 0
Kallithéa
Country [5] 0 0
Greece
State/province [5] 0 0
Piraeus
Country [6] 0 0
Greece
State/province [6] 0 0
Thessaloníki
Country [7] 0 0
Italy
State/province [7] 0 0
Milan
Country [8] 0 0
Italy
State/province [8] 0 0
Modena
Country [9] 0 0
Italy
State/province [9] 0 0
Napoli
Country [10] 0 0
Italy
State/province [10] 0 0
Novara
Country [11] 0 0
Italy
State/province [11] 0 0
Palermo
Country [12] 0 0
Italy
State/province [12] 0 0
Piacenza
Country [13] 0 0
Italy
State/province [13] 0 0
Pisa
Country [14] 0 0
Italy
State/province [14] 0 0
Salerno
Country [15] 0 0
Italy
State/province [15] 0 0
Siena
Country [16] 0 0
Mexico
State/province [16] 0 0
Mexico City
Country [17] 0 0
Netherlands
State/province [17] 0 0
Amsterdam
Country [18] 0 0
North Macedonia
State/province [18] 0 0
Skopje
Country [19] 0 0
Portugal
State/province [19] 0 0
Porto
Country [20] 0 0
Romania
State/province [20] 0 0
Bucharest
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Tunisia
State/province [22] 0 0
La Marsa
Country [23] 0 0
Turkey
State/province [23] 0 0
Ankara
Country [24] 0 0
Turkey
State/province [24] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Other
Name
University of Siena
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Association of Cardiovascular Imaging
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05204238
Trial related presentations / publications
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Public notes

Contacts
Principal investigator
Name 0 0
Matteo Cameli, Prof
Address 0 0
Department of Medical Biotechnologies Division of Cardiology University of Siena
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
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Contact person for scientific queries