Model for Heart Failure ExAcerbation Reduction Trial

NCT01726985 | Completed

• 1 other identifier: 121368
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute on Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Hospital Readmission for CHF

  up to 1 year

Secondary Outcomes (1)

• CHF Mortality

  90 days, 180 days, 1 yr

Study Arms (1)

Patients hospitalized with CHF

Patients hospitalized with CHF Parameter Based Clinical Disposition

Other: Parameter Based Clinical Disposition

Interventions

Parameter Based Clinical Disposition 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

Patients hospitalized with CHF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged 18 and over hospitalized at Cleveland Clinic Florida with diagnosis of CHF.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Cleveland Clinic Florida: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Study Officials

• Marlow Hernandez

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: November 15, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 11, 2017

Record last verified: 2012-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)