Validity of Scales to Assess Severity in Acute Heart Failure (AHFRS)

July 9, 2020 updated by: Susana García Gutiérrez, Hospital Galdakao-Usansolo

Validition of Scales for the Assessment of Sverity in Acute Decompensated Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1854

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Poor evolution
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
readmission
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jose María Quintana, PhD, Chief of Research unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 7, 2015

Study Record Updates

Last Update Posted (Actual)

July 13, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011111045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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