NCT04008914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
492

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

July 2, 2019

Last Update Submit

July 3, 2019

Conditions

Keywords

Heart FailureReadmission Risks

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

readmission at 30 days

Other: retrospective observation

readmission at 90 days

Other: retrospective observation

Interventions

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 30 daysreadmission at 90 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ascension Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Dustin Harmon, DO

    Ascension Macomb-Oakland Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 5, 2019

Study Start

August 1, 2017

Primary Completion

March 1, 2018

Study Completion

January 18, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations