The Predictors and Benefits of Multi-discipline Disease Management Program in Heart Failure Patients

The investigator will investigate the predictors includes cardiac biomarkers, endothelial function and cardiopulmonary exercise test in prediction of cardiovascular outcome in patients with heart failure discharged from hospital.

Study Overview

• Status: Completed
• Conditions: Heart Failure With Decompensation
• Intervention / Treatment: Behavioral: multi-discipline disease management program

Detailed Description

Background: Readmission and mortality are high after heart failure (HF) hospitalization. Heart Failure Multi-discipline disease management program (HFDMP) has shown to decrease 30% in readmission for decompensated heart failure or other cardiovascular causes. This was associated with a decreased in medical cost of care and a trend towards a lower mortality rate. Despite evidence that HFDMPs is effective, however, they are not widely employed in Taiwan. Some HFDMPs did not show improved health status compared with usual care. The "best way" to design and implement a HFDMP is not clear. It is still not clear if HFDMP would benefit all heart failure patients or should instead be targeted to specific subsets. Lysyl oxidase-like 2 (Loxl2) is enzyme, which crosslinks collagen in fibrotic processes such like liver cirrhosis or lung fibrosis. Recently, Lysyl oxidase-like 2 (Loxl2) was also found to participate the process of cardiac interstitial fibrosis and heart failure. Interestingly, the serum level of Loxl2 is in good correlation with the severity of heart failure. However, there is still unknown whether Loxl2 is useful biomarker for predicting the long-term outcome in patient with heart failure. From the mechanism of Loxl2 in the process of heart failure, the serum level of Loxl2 may be a good maker for predict the degree of cardiac remodeling. Our animal study showed the correlation between myocardial fibrosis and Loxl2 serum level. Therefore, The investigator will investigate whether serum Loxl2 level is a good maker for predictor the long-term outcome in patient with heart failure and predictor of cardiac remodeling. The correlation between this novel cardiac biomarker and endothelial function, cardiopulmonary function test will also be evaluated.

Objectives: The investigator will investigate the predictors includes cardiac biomarkers ( such as serum Loxl2 level, B-type natriuretic peptide (BNP), soluble ST2), endothelial function and cardiopulmonary exercise test in prediction of cardiovascular outcome and reverse remodeling in patients with heart failure discharged from hospital.

Design: A prospective cohort study

• Study Type: Observational
• Enrollment (Actual): 162

Contacts and Locations

• Study Contact: Name: Tzu-Hsien Tsai, MD; Phone Number: +886975056138; Email: garytsai@cgmh.org.tw
• Study Contact Backup: Name: Hsin-yen Tsai; Phone Number: +886929610850; Email: milktea588@gmail.com

Study Locations

• Taiwan
  • Bird Pine Area
    • Kaohsiung, Bird Pine Area, Taiwan, 83341
      • Chang Gung Memorial Hospital Heart Failure Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients population who admitted to a referred medical center.

Description

Inclusion Criteria:

1. Patients must give written informed consent before any assessment is performed.
2. Inpatients ≥ 18 years of age, male or female.
3. Patients with a diagnosis of heart failure New York Heart Association (NYHA) class II-IV with BNP >100 pg/mL

Exclusion Criteria:

1. Estimated survival time < 6 months
2. Long-term bedridden more than 3 months
3. Cannot tolerance exercise test due to muscular skeletal disorder
4. Cannot co-operate all functional studies
5. Ventilator dependent
6. Terminal heart status
7. Family reject to participate this project

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Readmission	Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF readmission.	up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Month 6 , Month 12
Number of Participants - All-cause Mortality	Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure (HF) patients. This measures how many patients had this event.	up to 36 months
Number of Participants with changes in ventricular shape using echocardiographic endocardial surface analysis techniques	Number of Participants with changes in ventricular shape using echocardiographic endocardial surface analysis techniques from patient discharge to 12 months after	12 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Shyh-Ming Chen, MD, Chang Gung Memorial Hospital Heart Failure Center

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2019
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Heart failure,; Reverse remodeling; Cardiopulmonary exercise test; Cardiac biomarker; Multi-discipline disease management program
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CMRPG8H1271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will discuss with other investigators about individual participant data (IPD) sharing.

Drug and device information, study documents

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