Validation of a Mortality Prediction Model for Acutely Decompensated Heart Failure Patients

NCT00536367 | Completed

• 1 other identifier: 2005H0241
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this protocol is to determine if the 3 variable mortality prediction model established using data from a retrospective, multi-center patient registry (The ADHERE Acute Decompensated HEart FailuRE National Registry) will hold for a prospective, observational outcome study of OSU patients diagnosed in the Emergency Department (ED)with Acute Decompensated Heart Failure (ADHF). In the retrospective registry, three parameters were found to be highly predictive of inpatient mortality for patients admitted with ADHF - on admission, BUN \> 43 mg/dL, systolic BP \< 115 mmHg, and Cr \> 2.75 mg/dL. However, the very nature of the ADHERE database limited the analytic potential of this model, as the data captured by ADHERE is retrospective and limited to the inpatient stay, and the only outcome evaluated was inpatient mortality. Due to its inherent limitations, the model did not and could not address longer term outcomes, such as repeat visits to the emergency department after discharge, or need for readmission to an acute care setting, which frequently occurs soon after discharge in patients who survive to discharge after being admitted with ADHF. This observational study will create a registry of patient information obtained from an interview with the patient and a review of the patient's medical record. Follow up information at 30 days post discharge will be obtained by phone interview with the patient and a review of the patient's OSUMC visit history. Most ED patients diagnosed with ADHF are admitted, as emergency physicians are aware that heart failure in general carries a very high mortality rate. However, as risk stratification for ADHF is a severely under researched area, it is not at all clear which patients with acutely decompensated heart failure will have a poor outcome in the short and intermediate term. With an improved understanding of the risk profile of our ADHF patients, more appropriate decision making and disposition assignment can be made.

Conditions

Heart Failure, Congestive

Keywords

Heart Failure, Congestive; Mortality Prediction Model

Outcome Measures

Primary Outcomes (1)

• 30 day admit rate

  examination of 30 day recidivism for heart failure admission patients

  30 days

Study Arms (1)

Patients seen for ADHF at OSUMC

Other: No intervention - observational study only

Interventions

No intervention - observational study only OTHER

Patients seen for ADHF at OSUMC

Eligibility Criteria

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

You may qualify if:

• age 18 or older
• presentation to the Emergency Department and/or admission to the hospital with diagnosis of acute decompensated heart failure

You may not qualify if:

• minors
• prisoners

Sponsors & Collaborators

• Brian Hiestand MD: lead
• Emergency Medicine Foundation: collaborator

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Brian C Hiestand, MD, MPH

  The Ohio State University Dept. of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 27, 2007
• Study Start: January 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: March 1, 2008
• Last Updated: June 12, 2014

Record last verified: 2014-06

Locations

US (1)