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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04008914
Other study ID # AscensionMacombOaklandH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date January 18, 2019

Study information

Verified date July 2019
Source Ascension Macomb-Oakland Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 492
Est. completion date January 18, 2019
Est. primary completion date March 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Ascension Macomb-Oakland Hospital Warren Michigan

Sponsors (1)

Lead Sponsor Collaborator
Ascension Macomb-Oakland Hospital

Country where clinical trial is conducted

United States, 

Outcome

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