Model for Heart Failure ExAcerbation Reduction Trial (HEART)

April 10, 2017 updated by: Cleveland Clinic Florida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital Readmission for CHF
Time Frame: up to 1 year
up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
CHF Mortality
Time Frame: 90 days, 180 days, 1 yr
90 days, 180 days, 1 yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleveland Clinic Florida

Investigators

  • Principal Investigator: Marlow Hernandez, Cleveland Clinic Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 15, 2012

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121368

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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