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Prognosis Predictors for Heart Failure

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04838470
Collaborator
(none)
792
Enrollment
134.9
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: cardiac rehabilitation

Detailed Description

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. The prognostic factors provide information about the treatment of this disease in the future. This study is a retrospective observational study. Investigators will collect data from May 2014 to July 2019 in the heart failure center of Kaohsiung Chang Gung Memorial Hospital. A follow-up is conducted at the Kaohsiung HF center until August 2020. Investigators want to know whether the risk factors such as atrial fibrillation, diabetes, nephropathy, and some biochemical indexes can be an index that predicts future survival or rehospitalization of these patients. Besides, investigators will also explore the cardiac rehabilitation can also effectively improve the survival rate of such patients.

Study Design

Study Type:
Observational
Actual Enrollment :
792 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Looking for Prognostic Factors That Affect the Survival of Patients With Heart Failure
Actual Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Mar 30, 2021

Outcome Measures

Primary Outcome Measures

  1. all-cause mortality [May, 2014 ~ August 2020]

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

Secondary Outcome Measures

  1. first heart failure rehospitalization [May, 2014 ~ August 2020]

    Number of Participants That Had Occurrence of the Endpoint, Which is Defined as First Heart Failure (HF) Hospitalization

  2. 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]

    Change from baseline to Month 6 and month 12 for the Kansas City Cardiomyopathy Questionnaire short form (KCCQ12) clinical summary score. KCCQ12 is a 12-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ12 clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04838470
Other Study ID Numbers:
  • 202001285B0
First Posted:
Apr 9, 2021
Last Update Posted:
Apr 9, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chang Gung Memorial Hospital
cardiac rehabilitation
multidisciplinary program
heart failure
mortality
renin-angiotensin-aldosterone system
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Apr 9, 2021