Prospective Registry of Acute Heart Failure

May 4, 2023 updated by: Sebastian Carballo

Context:

Heart failure is associated with a high morbidity and mortality rate and represents a significant worldwide public health burden. In European countries, the total amount of the expenses related to heart failure represents 1 to 2% of the total health budget with 75% spent during hospitalizations, making heart failure the most expensive pathology in cardiology. Acute heart failure (AHF) has a poor prognosis despite improvements in therapy. Hospital mortality is 2 to 4% the risk of death or readmission in the six months following hospitalization is high.

Patients hospitalized for heart failure represent a very heterogeneous population in terms of etiologies, clinical presentations and/or co-morbidities. Consequently, this implies variable outcomes in terms of morbidity and mortality, probably due to their different prognostic factors. The precise spectrum of etiologies and prognostic factors of AHF in non selected populations has not been exhaustively studied and only a few predictive models concerning AHF have been validated.

Ischemic heart disease, valvulopathy, arrhythmias, infections, hypertension and lack of therapeutic compliance are often quoted as being the factors triggering heart failure. Some triggering factors (ischemic heart disease, pulmonary infections, acute renal failure) seem to be strongly associated with a poor prognosis in terms of hospital/out-patient mortality and re-hospitalization rate.

The complex relation between heart failure and acute renal failure is defined by the cardio-renal syndrome. Thirty percent of patients hospitalized for AHF will be diagnosed with an acute renal failure at admission or with worsening kidney failure during hospitalization. It seems that heart failure and cardio-renal syndrome are two distinct entities with a different prognosis. The type of acute renal failure (functional, renal or post-renal) in these patients and the prognostic value of these etiologies is still not firmly established.

A thorough determination of the etiologies and prognostic factors of AHF are necessary in order to allow the identification of high-risk patients and the improvement of heart failure management.

Objectives:

  • To create an observational registry of all patients hospitalized for a AHF
  • To determine the precise prevalence of etiologies and the prognostic factors of AHF in a non selected population. Among the prognostic factors, to establish the specific role of acute renal failure
  • To establish the optimal initial assessment of patients hospitalized for heart failure
  • To validate and compare with prospective data the results of a retrospective cohort study carried out at the University Hospital of Geneva who established the re-hospitalization and mortality outcome of patients hospitalized for heart failure.

Method:

Creation of an observational registry associated with a biobank including patients hospitalized for AHF in the Department of General Internal medicine (SMIG) and in the Departments of Specialties at the University Hospital of Geneva.

Anticipated results:

  • To identify the prevalence of the etiologies and the prognostic factors of the heart failure
  • To establish the optimal initial assessment of the patients hospitalized for a heart failure. Among the prognostic factors, to establish the specific role of acute renal failure
  • To validate and compare results of a retrospective cohort study carried out at the University Hospital of Geneva which established the re-hospitalization and mortality outcome of patients hospitalized AHF
  • To improve the management of hospitalized patients with AHF with a robust identification of the etiologies and a better identification of high-risk patients.

Study Overview

Status

Status

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Recruiting

Conditions

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Intervention / Treatment

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Study Type

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Observational

Enrollment (Anticipated)

Enrollment

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1200

Contacts and Locations

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Study Locations

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Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized for an acute heart failure

Description

Inclusion Criteria:

  • Usual clinical presentation of acute heart failure as defined by the European Society of Cardiology : Gradual onset or new or worsening symptoms of rapid heart failure (eg, dyspnea, edema of the lower limbs and tiredness ) and signs of heart failure (eg elevation of jugular venous pressure, crackles, moving the shock peak) requiring urgent treatment.
  • Brain natriuretic peptide or value of brain natriuretic peptide (BNP) greater than 100 ng / L.

Exclusion Criteria:

  • Inability or refusal to consent to participate in the study cohort.

Study Plan

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How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Prevalence of different clinical presentations of the acute heart failure
Time Frame: baseline
baseline
Prevalence of the triggers of the acute heart failure
Time Frame: baseline
baseline
Prognostic factors (including the acute renal failure and worsening renal function) in the acute heart failure
Time Frame: baseline
baseline
Rehospitalization and early and late mortality
Time Frame: 30 days, 90days, 1 year and 2 years
30 days, 90days, 1 year and 2 years

Collaborators and Investigators

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Sponsor

Sponsor

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Sebastian Carballo

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

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December 1, 2014

Primary Completion (Anticipated)

Primary Completion

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November 1, 2026

Study Completion (Anticipated)

Study Completion

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November 1, 2026

Study Registration Dates

First Submitted

First Submitted

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May 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

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May 13, 2015

First Posted (Estimate)

First Posted

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May 14, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

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May 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

Last Verified

Last Verified

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May 1, 2023

More Information

Terms related to this study

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-019

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