Model for Heart Failure ExAcerbation Reduction Trial

Study Overview
=================
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).

Official Title
-----------------
Model for Heart Failure ExAcerbation Reduction Trial - Model HEART

Conditions
-----------------
Acute on Chronic Heart Failure

Intervention / Treatment
-----------------
* Other: Parameter Based Clinical Disposition


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients hospitalized with CHF<br>Patients hospitalized with CHF Parameter Based Clinical Disposition | Other: Parameter Based Clinical Disposition<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Readmission for CHF |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHF Mortality |  | 90 days, 180 days, 1 yr |