Prognosis Predictors for Heart Failure

Completed

• Conditions: Heart Failure; Life Quality; Hospitalization; Rehabilitation; Morality

• Registration Number: NCT04838470
• Lead Sponsor: Chang Gung Memorial Hospital

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.

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 Timeline

• Study Start: 2010-01-01
• Primary Completion: 2020-06-30
• Study Completion: 2021-03-30
• Status Verified: 2021-04
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-07
• Last Update Submitted: 2021-04-07
• Study First Posted: 2021-04-09
• Last Update Posted: 2021-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 792

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.