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

February 27, 2024 updated by: Hospital Clinic of Barcelona

Evaluation of the Impact of the MEESSI-AHF Scale on Decision Making and the Prognosis of Patients Diagnosed With Acute Heart Failure in the Emergency

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

3200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Albacete, Spain
        • Terminated
        • Emergency Department, Hospital de Albacete
      • Alicante, Spain
        • Recruiting
        • Emergency Department, Hospital Dr. Balmis
        • Contact:
          • Pere Llorens, PhD
      • Barcelona, Spain
        • Recruiting
        • Emergency Department, Hospital de Sant Pau
        • Contact:
          • Aitor Alquezar, PhD
      • Barcelona, Spain
        • Recruiting
        • Emergency Department, Hospital del Mar
        • Contact:
          • Alfons Aguirre, PhD
      • Barcelona, Spain
        • Recruiting
        • Emergency Department, Hospital Vall d'Hebron
        • Contact:
          • Eva Domingo, PhD
      • Burgos, Spain
        • Recruiting
        • Hospital Universitario de Burgos
        • Contact:
          • Pilar López-Díez, PhD
      • Ciudad Real, Spain
        • Recruiting
        • Emergency Department, Hospital La Mancha
        • Contact:
          • Maica Martínez, MD
      • Madrid, Spain
        • Recruiting
        • Emergency Department, Hospital Dr. Gregorio Marañón
        • Contact:
          • Jose Andueza, MD
      • Madrid, Spain
        • Recruiting
        • Emergency Department, Hospital Infanta Leonor
        • Contact:
          • Carlos Bibiano, MD
      • Salamanca, Spain
        • Recruiting
        • Emergency Department, Hospital de Salamanca
        • Contact:
          • Marta Fuentes de Frutos, MD
      • Santander, Spain
        • Recruiting
        • Emergency Department, Hospital Marques de Valdecilla
        • Contact:
          • Héctor Alonso, PhD
      • Tarragona, Spain
        • Recruiting
        • Emergency Department, Hospital Sant Pau i Santa Tecla
        • Contact:
          • Enrique Martin, MD
      • Valencia, Spain
        • Recruiting
        • Emergency Department, Hospital Dr. Peset
        • Contact:
          • Maria Luisa Lopez Grima, MD
      • Valencia, Spain
        • Recruiting
        • Emergency Department, Hospital La Fe
        • Contact:
          • Javier Millán, PhD
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain
        • Recruiting
        • Emergency Department, Hospital de Bellvitge
        • Contact:
          • Javier Jacob, PhD
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Recruiting
        • Emergency department
        • Contact:
    • Madrid
      • Getafe, Madrid, Spain
        • Recruiting
        • Emergency Department, Hospital de Getafe
        • Contact:
          • Nerea, MD
      • Móstoles, Madrid, Spain
        • Recruiting
        • Emergency Department, Hospital de Móstoles
        • Contact:
          • Marta Romero, MD
    • Valencia
      • Gandia, Valencia, Spain
        • Recruiting
        • Emergency Department, Hospital de Gandia
        • Contact:
          • Maria José Fortuny, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • ST-elevation acute coronary syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INTERVENTION
Once AHF has been diagnosed at ED, and before decision-making about hospitalize/discharge home is taken, physicians will objectively measure the severity of decompensation, based on risk of 30-day death using MEESSI scale. As result, patient can be allocated to low, intermediate, high or very-high risk. For patients classified as low-risk, the propocol recommendation will be discharge patient to home. For patients classified as increased risk (i.e., intermediate, high or very-high risk categories), the protocol recommendation will be to hospitalize patient. Nonetheless, final decission will be left to emergency physician, and overruling (disposition against recommendation) will be allowed. For discharged patients, there is no follow up intervention planned, and it will be based on current centre protocols.For hospitalized patients, department of admission will be based on current centre protocols, with no intervention at this level.
Procedure: Risk stratification before decision-making about patient hospitalization or discharge
Once AHF has been diagnosed at ED, and before decision-making about hospitalize/discharge home is taken, physicians will objectively measure the severity of decompensation, based on risk of 30-day death using MEESSI scale. As result, patient can be allocated to low, intermediate, high or very-high risk. For patients classified as low-risk, the propocol recommendation will be discharge patient to home. For patients classified as increased risk (i.e., intermediate, high or very-high risk categories), the protocol recommendation will be to hospitalize patient. Nonetheless, final decission will be left to emergency physician, and overruling (disposition against recommendation) will be allowed.
No Intervention: USUAL CARE
Once AHF has been diagnosed at ED, emergency physicians will decide patient disposition according to their usual strategies of care, that currently do not include risk stratification. For discharged patients, there is no follow up intervention planned, and it will be based on current centre protocols. For hospitalized patients, department of admission will be based on current centre protocols, with no intervention at this level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day all cause death
Time Frame: Through study completion, an avarage of 1 year
Death for any cause since patient randomization (day 0) to day 30
Through study completion, an avarage of 1 year
Days alive and out of hospital
Time Frame: Through study completion, an avarage of 1 year
Number of days with patient staying out of hospital (it can be at home, et residencial nursing house, etc., but not at hospital) from randomization (day 0) to day 30.
Through study completion, an avarage of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint withing 30 days after discharge (ED revisit due to AHF, hospitalization due to AHF or all-cause death)
Time Frame: Through study completion, an avarage of 1 year
Event will be considered if patient present ED revisit due to AHF, hospitalization due to AHF or all-cause death from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.
Through study completion, an avarage of 1 year
ED revisit due to AHF within the 30 days after discharge
Time Frame: Through study completion, an avarage of 1 year
Event will be considered if patient present ED revisit due to AHF from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.
Through study completion, an avarage of 1 year
Hospitalization due to AHF within the 30 days after discharge
Time Frame: Through study completion, an avarage of 1 year
Event will be considered if patient is hospitalized due to AHF from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.
Through study completion, an avarage of 1 year
All-cause death within the 30 days after discharge
Time Frame: Through study completion, an avarage of 1 year
Event will be considered if patient dies from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.
Through study completion, an avarage of 1 year
Proportion of patients with AHF managed without hospitalization.
Time Frame: Through study completion, an avarage of 1 year
We will calcultate the percentage of patients with AHF that are entirely managed in the ED and sent home, without hospitalization
Through study completion, an avarage of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of causes of overruling
Time Frame: Through study completion, an avarage of 1 year
Causes of overruling will be analyzed
Through study completion, an avarage of 1 year
Sensitivity analysis per protocol
Time Frame: Through study completion, an avarage of 1 year
All previous analyses will be made just using patients of the intervention arm that were managed according to recommendation provided after risk stratification with MEESSI scale (i.e., disregarding patients for whom recommendation was overruled by the emergency physician)
Through study completion, an avarage of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Oscar Miro, PhD, Hospital CLinic, Barcelona, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2018/0233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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