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Model for Heart Failure ExAcerbation Reduction Trial (Model HEART)

This study is currently recruiting participants.
Verified November 2012 by Cleveland Clinic Florida
Sponsor:
Information provided by (Responsible Party):
Cleveland Clinic Florida
ClinicalTrials.gov Identifier:
NCT01726985
First received: November 12, 2012
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Acute on Chronic Heart Failure
 Other: Parameter Based Clinical Disposition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Model for Heart Failure ExAcerbation Reduction Trial - "Model HEART"

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Cleveland Clinic Florida:

Primary Outcome Measures:
  • Hospital Readmission for CHF [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CHF Mortality [ Time Frame: 90 days, 180 days, 1 yr ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: November 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients hospitalized with CHF 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726985

Locations
United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States
Contact: Marlow B Hernandez, D.O.     954-659-5488     hernanm3@ccf.org    
Contact: Jose E Collado, M.D.     954-659-5488     colladj@ccf.org    
Principal Investigator: Marlow B Hernandez, D.O.,M.P.H.            
Sub-Investigator: Jose E Collado, M.D.            
Sub-Investigator: Randall Schwartz, M.D.            
Sub-Investigator: Sergey Kachur, M.D.            
Sub-Investigator: Jose Muniz, M.D.            
Sub-Investigator: Nemer Dabage, M.D.            
Sub-Investigator: Jose Gascon, M.D.            
Sub-Investigator: Elsy V Navas, M.D.            
Sub-Investigator: Gian Novaro, M.D.            
Sub-Investigator: Craig Asher, M.D.            
Sub-Investigator: Darby Sider, M.D.            
Sponsors and Collaborators
Cleveland Clinic Florida
  More Information

No publications provided

Responsible Party: Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT01726985     History of Changes
Other Study ID Numbers: 121368
Study First Received: November 12, 2012
Last Updated: November 14, 2012
Health Authority: United States: Cleveland Clinic Foundation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013