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

NCT ID: NCT03782337

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 162 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-11
• Study Completion Date: 2023-07-31

Brief Summary

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.

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

Conditions

Heart Failure With Decompensation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

multi-discipline disease management program

The multi-discipline disease management program consists of nursing lead education program, dietitian consultation, psychologist consultation and assessment, and cardiac rehabilitation program by physical therapist.The cardiovascular lead nurse will contact the patient by telephone within 3 days after discharge. An appointment at the outpatient clinic will be arranged within 1 to 2 weeks after discharge. The purposes of the telephone call are to reinforce self-management and recognition of HF symptoms and to screen post-discharge health status.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shyh-Ming Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital Heart Failure Center

Locations

Chang Gung Memorial Hospital Heart Failure Center

Kaohsiung City, Bird Pine Area, Taiwan

Countries

Taiwan

Other Identifiers

CMRPG8H1271

Identifier Type: -

Identifier Source: org_study_id