Validity of Scales to Assess Severity in Acute Heart Failure

NCT ID: NCT02437058

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1854 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-05-31

Brief Summary

The scales measuring the severity of acute decompensate heart failure (ADHF) in emergency departments have not achieved an adequate discriminative ability for decision making. Objectives: 1) Identify baseline variables, and evolutionary variables that may provide a good predictive ability of the model.2) Create and validate clinical predictive rules of mortality during admission/a week after ED visit in those discharged from ED, 30 and 60 days after ED visit as well as identify predicitive factors of short-term readmission (90 days)Design: Prospective cohort study. The sociodemographics and clinical variables will be collected from emergency medical records to identify predictors. Outcome variables and evolution of variables will be collected from hospital medical records / ambulatory during admission and up to 90 days after the episode of ADHF. Baseline predictors and evolutionary variables will be identified through logistic regression models using 60% of the final sample. The models that best fit will be applied in 40% of the sample to assess the predictive validity of this scale.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

preidictive model

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• They were diagnosed as heart failure) HF is defined, clinically, as a syndrome in which patients have typical symptoms (e.g.breathlessness, ankle swelling, and fatigue) and signs (e.g. elevated jugular venous pressure, pulmonary crackles, and displaced apex beat) resulting from an abnormality of cardiac structure or function.(8) We included the following presentation of acute heart failure (AHF) at ED: acute decompensated heart failure, hypertensive acute heart failure, pulmonary oedema, cardiogenic shock, and high output failure. (9;10)

Exclusion Criteria

• Patients whose main diagnosis in the ER is different than acute heart failure and those not wishing to participate in the study or signing the informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Donostia

OTHER

Sponsor Role: collaborator

Hospital de Basurto

OTHER

Sponsor Role: collaborator

Hospital Galdakao-Usansolo

OTHER_GOV

Sponsor Role: lead

Responsible Party

Susana García Gutiérrez

MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose María Quintana, PhD

Role: STUDY_DIRECTOR

Chief of Research unit

References

Garcia-Gutierrez S, Quintana JM, Anton-Ladislao A, Gallardo MS, Pulido E, Rilo I, Zubillaga E, Morillas M, Onaindia JJ, Murga N, Palenzuela R, Ruiz JG; AHFRS Group. Creation and validation of the acute heart failure risk score: AHFRS. Intern Emerg Med. 2017 Dec;12(8):1197-1206. doi: 10.1007/s11739-016-1541-4. Epub 2016 Oct 11.

Reference Type: DERIVED

PMID: 27730492 (View on PubMed)

Other Identifiers

2011111045

Identifier Type: -

Identifier Source: org_study_id