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CompletedNCT04838470Updated Apr 9, 2021

Prognosis Predictors for Heart Failure

An observational study in Heart Failure, Rehabilitation and Morality, sponsored by Chang Gung Memorial Hospital. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-04-09.

Sponsored by Chang Gung Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
792
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure
  • Rehabilitation
  • Morality
  • Hospitalization
  • Life Quality

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Keywords

  • cardiac rehabilitation
  • multidisciplinary program
  • heart failure
  • mortality
  • renin-angiotensin-aldosterone system
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 792 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Sampling method
Non-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).

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
792 participants (actual)
Patient registry
No

Interventions

  • Othercardiac rehabilitation

    multidisciplinary disease management program

06

What researchers measure

Primary outcomes

  1. all-cause mortality

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

    Time frame: May, 2014 ~ August 2020

Secondary outcomes

  1. first heart failure rehospitalization

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

    Time frame: May, 2014 ~ August 2020

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

    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.

    Time frame: May , 2014 ~ August 2020

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — individual participant data sharing plan will be discussed with other investigators.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04838470
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Apr 9, 2021
Start date
Jan 1, 2010
Primary completion
Jun 30, 2020
Completion
Mar 30, 2021
Last update
Apr 9, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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