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Readmission Risk Factors and Heart Failure With Preserved Ejection Fraction

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ClinicalTrials.gov Identifier: NCT04008914
Recruitment Status : Completed
First Posted : July 4, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dustin Harmon, Ascension Macomb-Oakland Hospital

Tracking Information
First Submitted Date July 2, 2019
First Posted Date July 4, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date August 1, 2017
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 2, 2019)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04008914 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Readmission Risk Factors and Heart Failure With Preserved Ejection Fraction
Official Title Readmission Risk Factors and Heart Failure With Preserved Ejection Fraction
Brief Summary Retrospective review of 492 patient from a small community hospital who did not qualify for participation in the Connect HF study sponsored by DCRI.
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
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All
Condition
  • Heart Failure
  • Preserved Ejection Fraction
Intervention 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.
Study Groups/Cohorts
  • readmission at 30 days
    Intervention: Other: retrospective observation
  • readmission at 90 days
    Intervention: Other: retrospective observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 2, 2019)
492
Original Actual Enrollment Same as current
Actual Study Completion Date January 18, 2019
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04008914
Other Study ID Numbers AscensionMacombOaklandH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dustin Harmon, Ascension Macomb-Oakland Hospital
Study Sponsor Ascension Macomb-Oakland Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Dustin Harmon, DO Ascension Macomb-Oakland Hospital
PRS Account Ascension Macomb-Oakland Hospital
Verification Date July 2019