NCT04838470

Brief Summary

This study is looking for the predictors of the survival or rehospitalization of patients with heart failure with reduced ejection fraction. Participants who are discharged from an acute heart failure hospitalization are enrolled.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
792

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

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

January 1, 2010

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

10.5 years

First QC Date

April 6, 2021

Last Update Submit

April 7, 2021

Conditions

Heart FailureRehabilitationMoralityHospitalizationLife Quality

Keywords

cardiac rehabilitationmultidisciplinary programheart failuremortalityrenin-angiotensin-aldosterone system

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    Number of participants that had occurrence of the mortality which is defined as all-cause mortality

    May, 2014 ~ August 2020

Secondary Outcomes (2)

  • first heart failure rehospitalization

    May, 2014 ~ August 2020

  • Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score

    May , 2014 ~ August 2020

Interventions

cardiac rehabilitationOTHER

multidisciplinary disease management program

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 792 patients were recruited between May 2014 and July 2019 and follow-up conducted at the Kaohsiung HF center until August 2020. All patients were introduced to a multidisciplinary HF disease management program (HFDMP).

You may qualify if:

  • inpatient, age \>= 20 years old, male or female
  • patient with heart failure with a reduced ejection fraction and discharged alive from the hospital
  • received heart failure disease management program

You may not qualify if:

  • Estimated survival time \< 6 months
  • Long-term bedridden for more than 3 months
  • Cannot tolerance exercise test due to muscular-skeletal disorder
  • Cannot co-operate all functional studies
  • Ventilator dependent
  • Terminal heart status
  • The family reject to participate in this project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 9, 2021

Study Start

January 1, 2010

Primary Completion

June 30, 2020

Study Completion

March 30, 2021

Last Updated

April 9, 2021

Record last verified: 2021-04