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Clinical Trials/NCT01726985
NCT01726985
Completed
Not Applicable

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

Cleveland Clinic Florida1 site in 1 country230 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute on Chronic Heart Failure
Sponsor
Cleveland Clinic Florida
Enrollment
230
Locations
1
Primary Endpoint
Hospital Readmission for CHF
Status
Completed
Last Updated
9 years ago

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).

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
October 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

Hospital Readmission for CHF

Time Frame: up to 1 year

Secondary Outcomes

  • CHF Mortality(90 days, 180 days, 1 yr)

Study Sites (1)

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