Risk Stratification Using MEESSI-AHF Scale in ED and Impact on AHF Outcomes

Last updated: February 27, 2024
Sponsor: Hospital Clinic of Barcelona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Heart Failure

Chest Pain

Treatment

Risk stratification before decision-making about patient hospitalization or discharge

Clinical Study ID

NCT05919225
HCB/2018/0233
  • All Genders

Study Summary

Evaluate the impact the application of the MESSI-AHF scale (a risk stratification scale specifically derived and validated in patients diagnosed with acute heart failure, AHF) in decision making (admission vs. discharge) by emergency physicians in emergency departments (ED) and its potential impact on on the short-term prognosis of patients with AHF.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of AHF based on Framinham criteria
  • NT-proBNP >300 pg/mL
  • Patient able to consent

Exclusion

Exclusion Criteria:

  • ST-elevation acute coronary syndrome

Study Design

Total Participants: 3200
Treatment Group(s): 1
Primary Treatment: Risk stratification before decision-making about patient hospitalization or discharge
Phase:
Study Start date:
June 27, 2023
Estimated Completion Date:
December 31, 2024

Study Description

Study 1: A non-intervention study involving the consecutive inclusion of 3,200 patients with AHF in 16 Spanish EDs managed according to the usual practice. Individual risk will be retrospectively stratified according to the MEESSI-AHF scale, and we will analyze the distribution of the categories of risk in patients admitted and discharged and the prognosis of patients with low risk discharged from the ED and compare the events observed in this subgroup of patients with the recommended international standards. Study 2: This is a cuasiexperimental study in 8 EDs with consecutive inclusion of 1,600 patients with AHF managed according to the usual practice (without stratification of risk, pre-phase) and 1,600 patients managed after the implementation of the MEESSI-AHF scales for risk stratification before the final decision making in the ED (post-phase). If the patient has low risk the calculator will propose discharge; for the remaining categories of risk the calculator will propose patient admission. The final decision corresponds to the attending physician and if this decision differs from what was proposed, a reason will be given. Study 3: Open multicentre (8 EDs) randomized clinical trial (1:1) comparing the results obtained in the patients randomized to usual clinical practice (1,600 patients) with those obtained in the patients randomized to the use of the MEESSI-AHF scale for risk stratification (1,600 patients) prior to decision making. The dynamics of the decision proposed by the scale will be the same as that in Study 2. Main outcomes (Studies 1, 2, 3): Death (by any cause and cardiovascular cause) at 30 days and at 1 year; combined event (revisit to the ED or hospitalization for AHF or death) at 30 days post-discharge (global analysis of all the patients with AHF stratified by categories of risk); days alive and outside the hospital at 30 days after the index event (consultation to the ED); and proportion of patients managed without hospitalization.

Connect with a study center

  • Emergency Department, Hospital de Bellvitge

    Hospitalet de Llobregat, Barcelona
    Spain

    Active - Recruiting

  • Emergency department

    Barcelona, Catalonia 08036
    Spain

    Active - Recruiting

  • Emergency Department, Hospital de Getafe

    Getafe, Madrid
    Spain

    Active - Recruiting

  • Emergency Department, Hospital de Móstoles

    Móstoles, Madrid
    Spain

    Active - Recruiting

  • Emergency Department, Hospital de Gandia

    Gandia, Valencia
    Spain

    Active - Recruiting

  • Emergency Department, Hospital de Albacete

    Albacete,
    Spain

    Terminated

  • Emergency Department, Hospital Dr. Balmis

    Alicante,
    Spain

    Active - Recruiting

  • Emergency Department, Hospital Vall d'Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • Emergency Department, Hospital de Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

  • Emergency Department, Hospital del Mar

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario de Burgos

    Burgos,
    Spain

    Active - Recruiting

  • Emergency Department, Hospital La Mancha

    Ciudad Real,
    Spain

    Active - Recruiting

  • Emergency Department, Hospital Dr. Gregorio Marañón

    Madrid,
    Spain

    Active - Recruiting

  • Emergency Department, Hospital Infanta Leonor

    Madrid,
    Spain

    Active - Recruiting

  • Emergency Department, Hospital de Salamanca

    Salamanca,
    Spain

    Active - Recruiting

  • Emergency Department, Hospital Marques de Valdecilla

    Santander,
    Spain

    Active - Recruiting

  • Emergency Department, Hospital Sant Pau i Santa Tecla

    Tarragona,
    Spain

    Active - Recruiting

  • Emergency Department, Hospital Dr. Peset

    Valencia,
    Spain

    Active - Recruiting

  • Emergency Department, Hospital La Fe

    Valencia,
    Spain

    Active - Recruiting

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