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

NCT05919225 | Unknown

• 1 other identifier: HCB/2018/0233
• Study Type: interventional
• Target: 3,200
• Locations: 1 country
• Sites: 19

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.

Conditions

Acute Heart Failure; Emergencies

Outcome Measures

Primary Outcomes (2)

• 30-day all cause death

  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

  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 Outcomes (5)

• Composite endpoint withing 30 days after discharge (ED revisit due to AHF, hospitalization due to AHF or all-cause death)

  Through study completion, an avarage of 1 year

• ED revisit due to AHF within the 30 days after discharge

  Through study completion, an avarage of 1 year

• Hospitalization due to AHF within the 30 days after discharge

  Through study completion, an avarage of 1 year

• All-cause death within the 30 days after discharge

  Through study completion, an avarage of 1 year

• Proportion of patients with AHF managed without hospitalization.

  Through study completion, an avarage of 1 year

Other Outcomes (2)

• Analysis of causes of overruling

  Through study completion, an avarage of 1 year

• Sensitivity analysis per protocol

  Through study completion, an avarage of 1 year

Study Arms (2)

INTERVENTION

EXPERIMENTAL

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

USUAL CARE

NO INTERVENTION

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.

Interventions

Risk stratification before decision-making about patient hospitalization or discharge 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.

INTERVENTION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ST-elevation acute coronary syndrome

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (19)

Emergency Department, Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Emergency department

Barcelona, Catalonia, 08036, Spain

RECRUITING

Emergency Department, Hospital de Getafe

Getafe, Madrid, Spain

RECRUITING

Emergency Department, Hospital de Móstoles

Móstoles, Madrid, Spain

RECRUITING

Emergency Department, Hospital de Gandia

Gandia, Valencia, Spain

RECRUITING

Emergency Department, Hospital de Albacete

Albacete, Spain

TERMINATED

Emergency Department, Hospital Dr. Balmis

Alicante, Spain

RECRUITING

Emergency Department, Hospital de Sant Pau

Barcelona, Spain

RECRUITING

Emergency Department, Hospital del Mar

Barcelona, Spain

RECRUITING

Emergency Department, Hospital Vall d'Hebron

Barcelona, Spain

RECRUITING

Hospital Universitario de Burgos

Burgos, Spain

RECRUITING

Emergency Department, Hospital La Mancha

Ciudad Real, Spain

RECRUITING

Emergency Department, Hospital Dr. Gregorio Marañón

Madrid, Spain

RECRUITING

Emergency Department, Hospital Infanta Leonor

Madrid, Spain

RECRUITING

Emergency Department, Hospital de Salamanca

Salamanca, Spain

RECRUITING

Emergency Department, Hospital Marques de Valdecilla

Santander, Spain

RECRUITING

Emergency Department, Hospital Sant Pau i Santa Tecla

Tarragona, Spain

RECRUITING

Emergency Department, Hospital Dr. Peset

Valencia, Spain

RECRUITING

Emergency Department, Hospital La Fe

Valencia, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 28973663 RESULT

• 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.

  PMID: 29903688 RESULT

• 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.

  PMID: 30656867 RESULT

• 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.

  PMID: 30690646 RESULT

• 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.

  PMID: 31147102 RESULT

• 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.

  PMID: 33609116 RESULT

MeSH Terms

Conditions

Emergencies

Interventions

Drainage

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Oscar Miro, PhD

  Hospital CLinic, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Miro, PhD

CONTACT

(+34)638274489; omiro@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-lable, multicentre, randomized, low-intervention, non-pharmacological, clinical trial

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 26, 2023
• Study Start: June 27, 2023
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (19)