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Model for Heart Failure ExAcerbation Reduction Trial (HEART)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic ( Cleveland Clinic Florida )
ClinicalTrials.gov Identifier:
NCT01726985
First received: November 12, 2012
Last updated: April 10, 2017
Last verified: November 2012
  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:


Further study details as provided by The Cleveland Clinic ( Cleveland Clinic Florida ):

Primary Outcome Measures:
  • Hospital Readmission for CHF [ Time Frame: up to 1 year ]

Secondary Outcome Measures:
  • CHF Mortality [ Time Frame: 90 days, 180 days, 1 yr ]

Enrollment: 230
Study Start Date: November 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients hospitalized with CHF
Patients hospitalized with CHF Parameter Based Clinical Disposition
Other: 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

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
Cleveland Clinic Florida
Investigators
Principal Investigator: Marlow Hernandez Cleveland Clinic Florida
  More Information

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: April 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 20, 2017