Heart Failure Clinical Trial
Official title:
Looking for Prognostic Factors That Affect the Survival of Patients With Heart Failure
NCT number | NCT04838470 |
Other study ID # | 202001285B0 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2010 |
Est. completion date | March 30, 2021 |
Verified date | April 2021 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 792 |
Est. completion date | March 30, 2021 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | all-cause mortality | Number of participants that had occurrence of the mortality which is defined as all-cause mortality | May, 2014 ~ August 2020 | |
Secondary | first heart failure rehospitalization | Number of Participants That Had Occurrence of the Endpoint, Which is Defined as First Heart Failure (HF) Hospitalization | May, 2014 ~ August 2020 | |
Secondary | 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. |
May , 2014 ~ August 2020 |
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