Clinical trial NCT03782337: The Predictors and Benefits of Multi-discipline Disease Management Program in Heart Failure Patients
Official title: The Predictors and Benefits of Multi-discipline Disease Management Program in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Decompensation
Keywords: Heart failure,
Cardiac biomarker
Cardiopulmonary exercise test
Multi-discipline disease management program
Reverse remodeling
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients population who admitted to a referred medical center.

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

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

Primary outcomes:
measure: Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Readmission
timeFrame: up to 36 months
Secondary outcomes:
measure: Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score
timeFrame: Baseline, Month 6 , Month 12
measure: Number of Participants - All-cause Mortality
timeFrame: up to 36 months
measure: Number of Participants with changes in ventricular shape using echocardiographic endocardial surface analysis techniques
timeFrame: 12 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital Heart Failure Center
state: Bird Pine Area
Study officials:
affiliation: Chang Gung Memorial Hospital Heart Failure Center
name: Shyh-Ming Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: