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

NCT03782337 | Completed

• 1 other identifier: CMRPG8H1271
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Decompensation

Keywords

Heart failure,; Cardiac biomarker; Cardiopulmonary exercise test; Multi-discipline disease management program; Reverse remodeling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score

  Baseline, Month 6 , Month 12

• Number of Participants - All-cause Mortality

  up to 36 months

• Number of Participants with changes in ventricular shape using echocardiographic endocardial surface analysis techniques

  12 months

Interventions

multi-discipline disease management program BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients population who admitted to a referred medical center.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital Heart Failure Center

Kaohsiung City, Bird Pine Area, 83341, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. Biomarkers for cardiovascular disease, e.g., sST2, GDF15, and DNA testing for arrhythmogenic cardiomyopathy. 2. Cytokines, e.g., inflammation cytokines.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Shyh-Ming Chen, MD

  Chang Gung Memorial Hospital Heart Failure Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 20, 2018
• Study Start: January 11, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-06

Locations

TW (1)