NCT01726985

Model for Heart Failure ExAcerbation Reduction Trial

Model for Heart Failure ExAcerbation Reduction Trial - "Model HEART"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 230 (actual)
• Sponsor: Cleveland Clinic Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute on Chronic Heart Failure

Interventions

Type	Name	Description
OTHER	Parameter Based Clinical Disposition	Parameter Based Clinical Disposition' 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 following 3 criteria are met: * NT-ProBNP reduction of \> 23% from peak value during admission * Fluid Reduction of \> 1.3L (orders for I/O q8h required) * Serum Sodium of \> 135 mmol/L the day of planned discharge

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-11-15
• Last updated: 2017-04-11

Locations

1 site across 1 country: United States