Readmission Risk Factors and Heart Failure With Preserved Ejection Fraction

July 3, 2019 updated by: Dustin Harmon, Ascension Macomb-Oakland Hospital
Retrospective review of 492 patient from a small community hospital who did not qualify for participation in the Connect HF study sponsored by DCRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retrospective review of adults above the age of 18 with a primary diagnosis of HFpEF between August 2017 and March 2018. Subjects had to fall into one of two classifications (NYHA Class II-IV or ACC/AHA Stage B-D) and had a life expectancy greater than 6 months are included. Individuals with a terminal illness other than HF, prior heart transplant or on a transplant list, or current/ planned left ventricular assist device excluded. The primary objective of this study is to identify risk factors for readmission in patients discharged with a diagnosis of HFpEF.

Study Type

Observational

Enrollment (Actual)

492

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
    • Michigan
      • Warren, Michigan, United States, 48093
        • Ascension Macomb-Oakland Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All

Description

Inclusion Criteria:

  • History of Heart failure diagnosis admitted for treatment
  • Ejection fraction < 40% by echocardiogram

Exclusion Criteria:

  • Ejection fraction >40% by echocardiogram
  • Chronic Kidney disease requiring dialysis
  • Terminal illness
  • New onset diagnosis of Heart Failure

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
readmission at 30 days
Other: retrospective observation
Retrospective review of study patients excluded from the CONNECT- HF trial who were discharged with a diagnosis of HFpEF between August 1, 2017 and March 1, 2018. Readmission rate at 30 and 90 days along with patient demographics and associated comorbidities were analyzed.
readmission at 90 days
Other: retrospective observation
Retrospective review of study patients excluded from the CONNECT- HF trial who were discharged with a diagnosis of HFpEF between August 1, 2017 and March 1, 2018. Readmission rate at 30 and 90 days along with patient demographics and associated comorbidities were analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission Risk Factors and Heart Failure with Preserved Ejection Fraction
Time Frame: August 1, 2017 though March 1, 2018
Retrospective review to identify risk factors for readmission in patients discharged with a diagnosis of HFpEF.
August 1, 2017 though March 1, 2018

Collaborators and Investigators

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

Sponsor

Ascension Macomb-Oakland Hospital

Investigators

  • Principal Investigator: Dustin Harmon, DO, Ascension Macomb-Oakland Hospital

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 (Actual)

August 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

January 18, 2019

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AscensionMacombOaklandH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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