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Acute Heart FailureMEESSINCT05919225

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

A study testing Risk stratification before decision-making about patient hospitalization or discharge in people with Acute Heart Failure and Emergencies, run by Hospital Clinic of Barcelona at 19 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Heart Failure, Emergencies
What is being tested?
Risk stratification before decision-making about patient hospitalization or discharge
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,200 participants
Where
19 sitesSpain
Study dates
27 Jun 2023to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • ST-elevation acute coronary syndrome

Trial locations and contacts

19 sites in 1 country.

Oscar Miro, PhD contact

(+34)638274489

omiro@clinic.cat

19 sites in 1 country

Spain19 sites, 18 recruiting

  • Emergency Department, Hospital de Albacete

    Albacete

    Terminated

  • Emergency Department, Hospital Dr. Balmis

    Alicante

    Pere Llorens, PhD

    Recruiting

  • Emergency department

    Barcelona, Catalonia, 08036

    Oscar Miro, PhD, +34638274489, omiro@clinic.cat

    Recruiting

  • Emergency Department, Hospital de Sant Pau

    Barcelona

    Aitor Alquezar, PhD

    Recruiting

  • Emergency Department, Hospital del Mar

    Barcelona

    Alfons Aguirre, PhD

    Recruiting

  • Emergency Department, Hospital Vall d'Hebron

    Barcelona

    Eva Domingo, PhD

    Recruiting

  • Hospital Universitario de Burgos

    Burgos

    Pilar López-Díez, PhD

    Recruiting

  • Emergency Department, Hospital La Mancha

    Ciudad Real

    Maica Martínez, MD

    Recruiting

  • Emergency Department, Hospital de Gandia

    Gandia, Valencia

    Maria José Fortuny, MD

    Recruiting

  • Emergency Department, Hospital de Getafe

    Getafe, Madrid

    Nerea, MD

    Recruiting

  • Emergency Department, Hospital de Bellvitge

    L'Hospitalet de Llobregat, Barcelona

    Javier Jacob, PhD

    Recruiting

  • Emergency Department, Hospital Dr. Gregorio Marañón

    Madrid

    Jose Andueza, MD

    Recruiting

  • Emergency Department, Hospital Infanta Leonor

    Madrid

    Carlos Bibiano, MD

    Recruiting

  • Emergency Department, Hospital de Móstoles

    Móstoles, Madrid

    Marta Romero, MD

    Recruiting

  • Emergency Department, Hospital de Salamanca

    Salamanca

    Marta Fuentes de Frutos, MD

    Recruiting

  • Emergency Department, Hospital Marques de Valdecilla

    Santander

    Héctor Alonso, PhD

    Recruiting

  • Emergency Department, Hospital Sant Pau i Santa Tecla

    Tarragona

    Enrique Martin, MD

    Recruiting

  • Emergency Department, Hospital Dr. Peset

    Valencia

    Maria Luisa Lopez Grima, MD

    Recruiting

  • Emergency Department, Hospital La Fe

    Valencia

    Javier Millán, PhD

    Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Risk stratification before decision-making about patient hospitalization or discharge
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risk stratification before decision-making about patient hospitalization or dischargeProcedure or surgery

    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.

Study groups in NCT05919225
Study groupRoleWhat they receive
INTERVENTIONExperimentalOnce 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.
Receives: Procedure: Risk stratification before decision-making about patient hospitalization or discharge
USUAL CARENo interventionOnce 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day all cause death

    Death for any cause since patient randomization (day 0) to day 30

    Measured: Through study completion, an avarage of 1 year

  2. 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.

    Measured: Through study completion, an avarage of 1 year

Secondary outcomes (5)

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

    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.

    Measured: Through study completion, an avarage of 1 year

  2. ED revisit due to AHF within the 30 days after discharge

    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.

    Measured: Through study completion, an avarage of 1 year

  3. Hospitalization due to AHF within the 30 days after discharge

    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.

    Measured: Through study completion, an avarage of 1 year

  4. All-cause death within the 30 days after discharge

    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.

    Measured: Through study completion, an avarage of 1 year

  5. Proportion of patients with AHF managed without hospitalization.

    We will calcultate the percentage of patients with AHF that are entirely managed in the ED and sent home, without hospitalization

    Measured: Through study completion, an avarage of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start27 Jun 2023
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-lable, multicentre, randomized, low-intervention, non-pharmacological, clinical trial
Masking
None (open label)
Enrolment
3,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05919225
Sponsor's protocol ID
HCB/2018/0233
Acronym
MEESSI
Status last verified
May 2023
First submitted
25 May 2023
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28973663

  • 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.

    PubMed 29903688

  • 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.

    PubMed 30656867

  • 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.

    PubMed 30690646

  • 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.

    PubMed 31147102

  • 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.

    PubMed 33609116

Questions about this trial

What is this clinical trial studying?

A study testing Risk stratification before decision-making about patient hospitalization or discharge in people with Acute Heart Failure and Emergencies, run by Hospital Clinic of Barcelona at 19 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Oscar Miro, PhD ((+34)638274489, omiro@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day all cause death (time frame: Through study completion, an avarage of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05919225, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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