Prospective Registry of Acute Heart Failure

NCT02444416 | Recruiting

• 1 other identifier: 14-019
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (4)

• Prevalence of different clinical presentations of the acute heart failure

  baseline

• Prevalence of the triggers of the acute heart failure

  baseline

• Prognostic factors (including the acute renal failure and worsening renal function) in the acute heart failure

  baseline

• Rehospitalization and early and late mortality

  30 days, 90days, 1 year and 2 years

Interventions

blood sample PROCEDURE

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for an acute heart failure

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sebastian Carballo: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

RECRUITING

Related Publications (3)

• 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.

  PMID: 34640562 DERIVED

• 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.

  PMID: 32167679 DERIVED

• 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.

  PMID: 31618841 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Sebastian Carballo, MD

CONTACT

+41223729216; sebastian.carballo@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: December 1, 2014
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

CH (1)