Prospective Registry of Acute Heart Failure

NCT ID: NCT02444416

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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blood sample

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sebastian Carballo

OTHER

Sponsor Role lead

Responsible Party

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Sebastian Carballo

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Sebastian Carballo, MD

Role: CONTACT

+41223729216

Facility Contacts

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Sebastian Carballo

Role: primary

+41223729216

References

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Carballo D, Garin N, Stirnemann J, Mamin A, Prendki V, Meyer P, Marti C, Mach F, Reny JL, Serratrice J, Kaiser L, Carballo S. Prognosis of Laboratory-Confirmed Influenza and Respiratory Syncytial Virus in Acute Heart Failure. J Clin Med. 2021 Sep 30;10(19):4546. doi: 10.3390/jcm10194546.

Reference Type DERIVED
PMID: 34640562 (View on PubMed)

Carballo D, Stirnemann J, Garin N, Marti C, Serratrice J, Carballo S. Eligibility for sacubitril-valsartan in patients with acute decompensated heart failure. ESC Heart Fail. 2020 Jun;7(3):1282-1290. doi: 10.1002/ehf2.12676. Epub 2020 Mar 13.

Reference Type DERIVED
PMID: 32167679 (View on PubMed)

Carballo S, Musso P, Garin N, Muller H, Serratrice J, Mach F, Carballo D, Stirnemann J. Prognostic Value of the Echocardiographic Probability of Pulmonary Hypertension in Patients with Acute Decompensated Heart Failure. J Clin Med. 2019 Oct 15;8(10):1684. doi: 10.3390/jcm8101684.

Reference Type DERIVED
PMID: 31618841 (View on PubMed)

Other Identifiers

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14-019

Identifier Type: -

Identifier Source: org_study_id

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