Clinical trial NCT05919225: Risk Stratification Using MEESSI-AHF Scale in ED and Impact on AHF Outcomes
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Heart Failure
Emergencies
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2023-06-26
Enrollment: 3200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-lable, multicentre, randomized, low-intervention, non-pharmacological, clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 30-day all cause death
timeFrame: Through study completion, an avarage of 1 year
measure: Days alive and out of hospital
timeFrame: Through study completion, an avarage of 1 year
Secondary outcomes:
measure: Composite endpoint withing 30 days after discharge (ED revisit due to AHF, hospitalization due to AHF or all-cause death)
timeFrame: Through study completion, an avarage of 1 year
measure: ED revisit due to AHF within the 30 days after discharge
timeFrame: Through study completion, an avarage of 1 year
measure: Hospitalization due to AHF within the 30 days after discharge
timeFrame: Through study completion, an avarage of 1 year
measure: All-cause death within the 30 days after discharge
timeFrame: Through study completion, an avarage of 1 year
measure: Proportion of patients with AHF managed without hospitalization.
timeFrame: Through study completion, an avarage of 1 year
Other outcomes:
measure: Analysis of causes of overruling
timeFrame: Through study completion, an avarage of 1 year
measure: Sensitivity analysis per protocol
timeFrame: Through study completion, an avarage of 1 year
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Emergency Department, Hospital de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Emergency department
state: Catalonia
city: Getafe
country: Spain
facility: Emergency Department, Hospital de Getafe
state: Madrid
city: Móstoles
country: Spain
facility: Emergency Department, Hospital de Móstoles
state: Madrid
city: Gandia
country: Spain
facility: Emergency Department, Hospital de Gandia
state: Valencia
city: Albacete
country: Spain
facility: Emergency Department, Hospital de Albacete
city: Alicante
country: Spain
facility: Emergency Department, Hospital Dr. Balmis
city: Barcelona
country: Spain
facility: Emergency Department, Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Emergency Department, Hospital del Mar
city: Barcelona
country: Spain
facility: Emergency Department, Hospital Vall d'Hebron
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Ciudad Real
country: Spain
facility: Emergency Department, Hospital La Mancha
city: Madrid
country: Spain
facility: Emergency Department, Hospital Dr. Gregorio Marañón
city: Madrid
country: Spain
facility: Emergency Department, Hospital Infanta Leonor
city: Salamanca
country: Spain
facility: Emergency Department, Hospital de Salamanca
city: Santander
country: Spain
facility: Emergency Department, Hospital Marques de Valdecilla
city: Tarragona
country: Spain
facility: Emergency Department, Hospital Sant Pau i Santa Tecla
city: Valencia
country: Spain
facility: Emergency Department, Hospital Dr. Peset
city: Valencia
country: Spain
facility: Emergency Department, Hospital La Fe
Study officials:
affiliation: Hospital CLinic, Barcelona, Spain
name: Oscar Miro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.