Model for Heart Failure ExAcerbation Reduction Trial

Completed

• Conditions: Acute on Chronic Heart Failure
• Interventions: Other: Parameter Based Clinical Disposition

• Registration Number: NCT01726985
• Lead Sponsor: Cleveland Clinic Florida

Brief Summary

Heart failure is the leading cause of hospitalizations and readmissions in the United States and is a tremendous economic strain on our healthcare system. There is currently, based on national averages, a 30% readmission rate and 10% mortality rate within 3 months of being hospitalized for heart failure. Retrospective studies have shown benefit to using biomarkers such as BNP to guide inpatient heart failure management. Our own CCF retrospective study showed that decreasing NT-ProBNP by 23%, making patients fluid negative by more than 1.3L, and discharging patients with serum sodium above 135 reduces readmission rates significantly. The purpose of this study is to prospectively use the above mentioned goals in the treatment of heart failure in order to reduce heart failure readmission and mortality rates.

Detailed Description

All HF patients admitted to CCF will receive a short consent form. The study will enroll patients for one year. Physicians will initiate / titrate medications and obtain consults as usual but are highly encourage to keep patients in the hospital until at least 2 of the 3 (above mentioned) criteria are met. Physicians will receive a copy of consent forms, educational bulletins, and discharge forms (as described in the Physician Education document which is attached to this application). Log-rank test will be used to compare groups. Chi-Square will be used to compare prospective patients with retrospective controls (obtained in 2010).

Study Timeline

• Status Verified: 2012-11
• Study Start: 2012-11
• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-15
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Must have either Acute on Chronic Heart Failure or Chronic Heart Failure regardless of presenting/primary complaint

To fulfill CHF Dx, MUST have 2+ of the following:

• Clinical: Dyspnea, orthopnea, PND, edema, S3, rales, improve w diuretics
• Radiographic: Pulm venous congestion, pleural effs, cardiomegaly
• Lab: NT pro BNP > 1000

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients hospitalized with CHF	Parameter Based Clinical Disposition	Patients hospitalized with CHF Parameter Based Clinical Disposition

Primary Outcome Measures

Name	Time	Method
Hospital Readmission for CHF	up to 1 year

Secondary Outcome Measures

Name	Time	Method
CHF Mortality	90 days, 180 days, 1 yr

Trial Locations

Locations (1)

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States