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

NCT ID: NCT05919225

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-27
• Study Completion Date: 2024-12-31

Brief 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.

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.

Conditions

Acute Heart Failure; Emergencies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Risk stratification before decision-making about patient hospitalization or discharge

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oscar Miro, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital CLinic, Barcelona, Spain

Locations

Emergency Department, Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Emergency department

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Emergency Department, Hospital de Getafe

Getafe, Madrid, Spain

Site Status: RECRUITING

Emergency Department, Hospital de Móstoles

Móstoles, Madrid, Spain

Site Status: RECRUITING

Emergency Department, Hospital de Gandia

Gandia, Valencia, Spain

Site Status: RECRUITING

Emergency Department, Hospital de Albacete

Albacete, , Spain

Site Status: TERMINATED

Emergency Department, Hospital Dr. Balmis

Alicante, , Spain

Site Status: RECRUITING

Emergency Department, Hospital de Sant Pau

Barcelona, , Spain

Site Status: RECRUITING

Emergency Department, Hospital del Mar

Barcelona, , Spain

Site Status: RECRUITING

Emergency Department, Hospital Vall d'Hebron

Barcelona, , Spain

Site Status: RECRUITING

Hospital Universitario de Burgos

Burgos, , Spain

Site Status: RECRUITING

Emergency Department, Hospital La Mancha

Ciudad Real, , Spain

Site Status: RECRUITING

Emergency Department, Hospital Dr. Gregorio Marañón

Madrid, , Spain

Site Status: RECRUITING

Emergency Department, Hospital Infanta Leonor

Madrid, , Spain

Site Status: RECRUITING

Emergency Department, Hospital de Salamanca

Salamanca, , Spain

Site Status: RECRUITING

Emergency Department, Hospital Marques de Valdecilla

Santander, , Spain

Site Status: RECRUITING

Emergency Department, Hospital Sant Pau i Santa Tecla

Tarragona, , Spain

Site Status: RECRUITING

Emergency Department, Hospital Dr. Peset

Valencia, , Spain

Site Status: RECRUITING

Emergency Department, Hospital La Fe

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Oscar Miro, PhD

Role: CONTACT

omiro@clinic.cat

(+34)638274489

Facility Contacts

Javier Jacob, PhD

Role: primary

Oscar Miro, PhD

Role: primary

omiro@clinic.cat

+34638274489

Nerea, MD

Role: primary

Marta Romero, MD

Role: primary

Maria José Fortuny, MD

Role: primary

Pere Llorens, PhD

Role: primary

Aitor Alquezar, PhD

Role: primary

Alfons Aguirre, PhD

Role: primary

Eva Domingo, PhD

Role: primary

Pilar López-Díez, PhD

Role: primary

Maica Martínez, MD

Role: primary

Jose Andueza, MD

Role: primary

Carlos Bibiano, MD

Role: primary

Marta Fuentes de Frutos, MD

Role: primary

Héctor Alonso, PhD

Role: primary

Enrique Martin, MD

Role: primary

Maria Luisa Lopez Grima, MD

Role: primary

Javier Millán, PhD

Role: primary

References

Miro O, Rossello X, Gil V, Martin-Sanchez FJ, Llorens P, Herrero-Puente P, Jacob J, Bueno H, Pocock SJ; ICA-SEMES Research Group. Predicting 30-Day Mortality for Patients With Acute Heart Failure in the Emergency Department: A Cohort Study. Ann Intern Med. 2017 Nov 21;167(10):698-705. doi: 10.7326/M16-2726. Epub 2017 Oct 3.

Reference Type: RESULT

PMID: 28973663 (View on PubMed)

Miro O, Rossello X, Gil V, Martin-Sanchez FJ, Llorens P, Herrero P, Jacob J, Lopez-Grima ML, Gil C, Lucas Imbernon FJ, Garrido JM, Perez-Dura MJ, Lopez-Diez MP, Richard F, Bueno H, Pocock SJ. The Usefulness of the MEESSI Score for Risk Stratification of Patients With Acute Heart Failure at the Emergency Department. Rev Esp Cardiol (Engl Ed). 2019 Mar;72(3):198-207. doi: 10.1016/j.rec.2018.05.002. Epub 2018 Jun 11. English, Spanish.

Reference Type: RESULT

PMID: 29903688 (View on PubMed)

Miro O, Gil V, Rossello X, Martin-Sanchez FJ, Llorens P, Jacob J, Herrero P, Herrera Mateo S, Richard F, Escoda R, Fuentes M, Martin Mojarro E, Llauger L, Bueno H, Pocock S. Patients with acute heart failure discharged from the emergency department and classified as low risk by the MEESSI score (multiple risk estimate based on the Spanish emergency department scale): prevalence of adverse events and predictability. Emergencias. 2019 Feb;31(1):5-14. English, Spanish.

Reference Type: RESULT

PMID: 30656867 (View on PubMed)

Wussler D, Kozhuharov N, Sabti Z, Walter J, Strebel I, Scholl L, Miro O, Rossello X, Martin-Sanchez FJ, Pocock SJ, Nowak A, Badertscher P, Twerenbold R, Wildi K, Puelacher C, du Fay de Lavallaz J, Shrestha S, Strauch O, Flores D, Nestelberger T, Boeddinghaus J, Schumacher C, Goudev A, Pfister O, Breidthardt T, Mueller C. External Validation of the MEESSI Acute Heart Failure Risk Score: A Cohort Study. Ann Intern Med. 2019 Feb 19;170(4):248-256. doi: 10.7326/M18-1967. Epub 2019 Jan 29.

Reference Type: RESULT

PMID: 30690646 (View on PubMed)

Miro O, Rossello X, Gil V, Martin-Sanchez FJ, Llorens P, Herrero-Puente P, Jacob J, Pinera P, Mojarro EM, Lucas-Imbernon FJ, Llauger L, Aguera C, Lopez-Diez MP, Valero A, Bueno H, Pocock SJ; ICA-SEMES Research Group. Analysis of How Emergency Physicians' Decisions to Hospitalize or Discharge Patients With Acute Heart Failure Match the Clinical Risk Categories of the MEESSI-AHF Scale. Ann Emerg Med. 2019 Aug;74(2):204-215. doi: 10.1016/j.annemergmed.2019.03.010. Epub 2019 May 27.

Reference Type: RESULT

PMID: 31147102 (View on PubMed)

Rossello X, Bueno H, Gil V, Jacob J, Javier Martin-Sanchez F, Llorens P, Herrero Puente P, Alquezar-Arbe A, Raposeiras-Roubin S, Lopez-Diez MP, Pocock S, Miro O. MEESSI-AHF risk score performance to predict multiple post-index event and post-discharge short-term outcomes. Eur Heart J Acute Cardiovasc Care. 2021 Apr 8;10(2):142-152. doi: 10.1177/2048872620934318.

Reference Type: RESULT

PMID: 33609116 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HCB/2018/0233

Identifier Type: -

Identifier Source: org_study_id