Prospective Registry of Acute Heart Failure

Sponsor
Sebastian Carballo (Other)
Overall Status
Recruiting
CT.gov ID
NCT02444416
Collaborator
(none)
1,200
1
119
10.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: blood sample

Study Design

Study Type:
Observational
Anticipated Enrollment :
1200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Registry of Acute Heart Failure
Study Start Date :
Dec 1, 2014
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Prevalence of different clinical presentations of the acute heart failure [baseline]

  2. Prevalence of the triggers of the acute heart failure [baseline]

  3. Prognostic factors (including the acute renal failure and worsening renal function) in the acute heart failure [baseline]

  4. Rehospitalization and early and late mortality [30 days, 90days, 1 year and 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Geneva University Hospitals Geneva Switzerland 1211

Sponsors and Collaborators

  • Sebastian Carballo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sebastian Carballo, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT02444416
Other Study ID Numbers:
  • 14-019
First Posted:
May 14, 2015
Last Update Posted:
Jan 12, 2022
Last Verified:
Jan 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022