- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01416285
Impact of Heart Failure Center Program on Cardiac Outcomes in Patients With Heart Failure
March 7, 2024 updated by: luck5748, Chang Gung Memorial Hospital
The Impact of Heart Failure Center Program on The Progression of Biomarkers, Changes in Life Quality, Left Ventricular Ejection Fraction, and Cardiac Outcomes in Patients With Congestive Heart Failure
Congestive heart failure (CHF) is a major public health problem worldwide.
CHF carries a devastating prognosis, which resembles that of some types of malignant cancer.
Despite substantial improvements in the management of the disease, the prognosis remains poor especially in advanced stages of the disease.
For these patients, self-management plan includes monitoring of symptoms such as fatigue and shortness of breath, daily weighing, and knowing what to do if signs of deterioration appear, and when to report the changes to health.
The investigators hypothesize that patients in the heart failure management programs that promote self-management by means of intensive education, edema index-assistance, and telephone follow-up can improve their functional status and quality of life, as well as the biomarkers of CHF, left ventricular systolic function, proteinuria and nutritional status.
Study Overview
Status
Completed
Conditions
Detailed Description
Congestive heart failure (CHF) is a major public health problem world-wide.
CHF carries a devastating prognosis which resembles that of some types of malignant cancer.
Its incidence rises steadily from 0.02 per 1000 population per year in those aged 25 to 34 years to 11.6 in those aged 85 years or older.
Despite substantial improvements in the management of the disease, the prognosis remains poor especially in advanced stages of the disease.
About half of the patients diagnosed with CHF die within 4 years of diagnosis.
With the increasing number of patients with CHF being referred from hospital to primary health care, the demands for expanded services in primary health care have increased.
Caring for patients with CHF often involves a number of physical, medical, behavioral, psychological and social factors, and requires appropriate attention to all aspects of care, both pharmacological and non-pharmacological.
Educating patients about CHF treatment and the consequences of CHF has been shown to improve self-management behavior.
For patients with CHF, the self-management plan includes monitoring of symptoms such as fatigue and shortness of breath, daily weighing, and knowing what to do if signs of deterioration appear, and when to report the changes to health care provider.
In patients with CHF, the prognosis worsens considerably once malnutrition develops.
Mortality at 18 months in unselected patients with CHF in whom cardiac cachexia had been diagnosed was as high as 50% compared to in non-cachectic patients from the same study population.
In addition, amount of proteinuria has been known to be related to atherosclerosis burden and disease severity regarding lots of disease entities.
The atherosclerosis score is also probably modifiable by life style intervention and educational program.
CHF can also activate a few neurohormone and natriuretic peptides, among which brain natriuretic peptide is the most world-wide used.
Summarized, in this study, to estimate the effect of CHF education and self-management program, the parameters adopted include blood brain natriuretic peptide and albumin levels, atherosclerosis scores, proteinuria, renal function, changes in life quality, left ventricular ejection fraction, and cardiac outcomes.
In Taiwan, so far, the investigators don't have this kind of CHF education and self-care system.
The investigators hypothesize that patients in the heart failure management programs that promote self-management by means of intensive education, edema index-assistance, and telephone follow-up can improve their functional status and quality of life, as well as the biomarkers of CHF, left ventricular systolic function, proteinuria and nutritional status.
Study Type
Observational
Enrollment (Actual)
470
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Keelung, Taiwan, 402
- Chang Gung Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients hospitalized due to acute cardiogenic pulmonary edema will be consecutively enrolled in the HF center of Chang Gung Memorial Hospital.
Description
Inclusion Criteria:
- patients hospitalized due to acute cardiogenic pulmonary edema documented on chest x-ray and
- left ventricular ejection fraction (LVEF) < 40% as documented by echocardiography; and
- aged > 20 and < 80 years.
Exclusion Criteria:
- the presence of systemic diseases such as hypothyroidism, decompensated liver cirrhosis, and systemic lupus erythematosus;
- a disorder other than HF that might compromise survival within 6 months;
- having implanted materials that could interfere with the bioimpedance analysis,
- being bed-ridden for > 3 months and/or unable to stand alone;
- having serum creatinine of > 5 mg/dl or nephritic syndrome;
- having active cellulites, severe varicose veins, lymphedema or deep vein thrombosis over lower extremity;
- undergoing dialysis within 2 weeks;
- having severe coronary artery disease without complete revascularization therapy; and
- being pregnant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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control group
control group receiving regular education from a nurse
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Case management group
This is the study group.
Extensive education and case management program will be performed in this group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations
Time Frame: 2 year
|
Follow-up began after randomization.
Follow-up data were prospectively obtained every month from hospital records, personal communication with patients' physicians, telephone interviews, and records of regular visits to staff physicians' outpatient clinics.
'Re-hospitalization'was defined as heart failure-related re-hospitalization.'All
causes of death' was also considered to be an event.
All-cause death was chosen as an endpoint because of the inter-relationship of heart failure with many other comorbidities in the patient cohort.
A committee of three cardiologists adjudicated all hospitalizations without knowledge of the patients' clinical data to determine whether events were related to worsening heart failure.
Based on these two different endpoints, time to the first event was analyzed.
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2 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: CHAO-HUNG WANG, MD, Chang Gung Memorial Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jaarsma T, van der Wal MH, Lesman-Leegte I, Luttik ML, Hogenhuis J, Veeger NJ, Sanderman R, Hoes AW, van Gilst WH, Lok DJ, Dunselman PH, Tijssen JG, Hillege HL, van Veldhuisen DJ; Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH) Investigators. Effect of moderate or intensive disease management program on outcome in patients with heart failure: Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH). Arch Intern Med. 2008 Feb 11;168(3):316-24. doi: 10.1001/archinternmed.2007.83.
- Hoekstra T, Lesman-Leegte I, van der Wal M, Luttik ML, Jaarsma T. Nurse-led interventions in heart failure care: patient and nurse perspectives. Eur J Cardiovasc Nurs. 2010 Dec;9(4):226-32. doi: 10.1016/j.ejcnurse.2010.01.006. Epub 2010 Mar 4.
- Riegel B, Lee CS, Dickson VV; Medscape. Self care in patients with chronic heart failure. Nat Rev Cardiol. 2011 Jul 19;8(11):644-54. doi: 10.1038/nrcardio.2011.95.
- Mao CT, Liu MH, Hsu KH, Fu TC, Wang JS, Huang YY, Yang NI, Wang CH. Effect of multidisciplinary disease management for hospitalized heart failure under a national health insurance programme. J Cardiovasc Med (Hagerstown). 2015 Sep;16(9):616-24. doi: 10.2459/JCM.0000000000000089.
- Liu MH, Wang CH, Huang YY, Tung TH, Lee CM, Yang NI, Liu PC, Cherng WJ. Edema index established by a segmental multifrequency bioelectrical impedance analysis provides prognostic value in acute heart failure. J Cardiovasc Med (Hagerstown). 2012 May;13(5):299-306. doi: 10.2459/JCM.0b013e328351677f.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2010
Primary Completion (Actual)
May 30, 2012
Study Completion (Actual)
May 30, 2012
Study Registration Dates
First Submitted
August 11, 2011
First Submitted That Met QC Criteria
August 12, 2011
First Posted (Estimated)
August 15, 2011
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 7, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 98-1154B
- CMRPG280251 (Other Grant/Funding Number: CHANG GUNG MEMORIAL HOSPITAL)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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