Heart Failure With DecompensationNCT03782337
The Predictors and Benefits of Multi-discipline Disease Management Program in Heart Failure Patients
An observational study of Heart Failure With Decompensation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Decompensation
- What is being tested?
- multi-discipline disease management program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 162 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jan 2019to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients population who admitted to a referred medical center.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital Heart Failure Center
Kaohsiung City, Bird Pine Area, 83341
About this study
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.
Read the 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
- Being tested
- multi-discipline disease management program
- Keywords
- Heart failure,, Cardiac biomarker, Cardiopulmonary exercise test, Multi-discipline disease management program, Reverse remodeling
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-discipline disease management programBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start11 Jan 2019
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With DecompensationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyh-Ming Chen, MD, Principal investigator, Chang Gung Memorial Hospital Heart Failure Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782337
- Sponsor's protocol ID
- CMRPG8H1271
- Status last verified
- Jun 2023
- First submitted
- 5 Dec 2018
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will discuss with other investigators about individual participant data (IPD) sharing.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictors and Benefits of Multi-discipline Disease Management Program in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT03782337
- Acronym / sponsor ID
- CMRPG8H1271
- Conditions
- Heart Failure With Decompensation
- Keywords
- Heart failure,, Cardiac biomarker, Cardiopulmonary exercise test, Multi-discipline disease management program, Reverse remodeling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients population who admitted to a referred medical center.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-discipline disease management programThe 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. | Behavioural | – |
Primary outcome
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Readmission
Time frame: up to 36 months
Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF readmission.
3 secondary outcomes
Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score
Time frame: Baseline, Month 6 , Month 12
Number of Participants - All-cause Mortality
Time frame: up to 36 months
Number of Participants with changes in ventricular shape using echocardiographic endocardial surface analysis techniques
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Undecided. We will discuss with other investigators about individual participant data (IPD) sharing.
Related trials for Heart Failure With Decompensation
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Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
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Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients With Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement
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Association Between the Sit-To-Stand Test and the Prognosis of Patients With Heart Failure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyh-Ming Chen, MD principal investigator
Chang Gung Memorial Hospital Heart Failure Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Decompensation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.