Model for Heart Failure ExAcerbation Reduction Trial

NCT ID: NCT01726985

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-10-31

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).

Conditions

Acute on Chronic Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients hospitalized with CHF

Patients hospitalized with CHF Parameter Based Clinical Disposition

Parameter Based Clinical Disposition

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cleveland Clinic Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marlow Hernandez

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Countries

United States

Other Identifiers

121368

Identifier Type: -

Identifier Source: org_study_id