Prognosis Predictors for Heart Failure

Looking for Prognostic Factors That Affect the Survival of Patients With Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Rehabilitation; Hospitalization; Morality; Life Quality
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 792

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: 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).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	Number of participants that had occurrence of the mortality which is defined as all-cause mortality	May, 2014 ~ August 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: heart failure; mortality; renin-angiotensin-aldosterone system; cardiac rehabilitation; multidisciplinary program
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 202001285B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: individual participant data sharing plan will be discussed with other investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No