Validity of Scales to Assess Severity in Acute Heart Failure

NCT02437058 | Completed

• 1 other identifier: 2011111045
• Study Type: observational
• Target: 1,854
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Poor evolution

  3 months

Secondary Outcomes (1)

• readmission

  3 months

Interventions

preidictive model OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms of acute decompensated heart failure who attended the emergency departments of 3 hospitals belonging to the Basque National Health Service

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead
• Hospital Donostia: collaborator
• Hospital de Basurto: collaborator

Related Publications (1)

• 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.

  PMID: 27730492 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jose María Quintana, PhD

  Chief of Research unit

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 7, 2015
• Study Start: January 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2015
• Last Updated: July 13, 2020

Record last verified: 2020-07