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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

20 Years
80 Years
Open (Enrolling)
Death, Congestive Heart Failure

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Trial Information

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 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.

Inclusion Criteria:

1. patients hospitalized due to acute cardiogenic pulmonary edema documented on chest
x-ray and

2. left ventricular ejection fraction (LVEF) < 40% as documented by echocardiography;

3. aged > 20 and < 80 years.

Exclusion Criteria:

1. the presence of systemic diseases such as hypothyroidism, decompensated liver
cirrhosis, and systemic lupus erythematosus;

2. a disorder other than HF that might compromise survival within 6 months;

3. having implanted materials that could interfere with the bioimpedance analysis,

4. being bed-ridden for > 3 months and/or unable to stand alone;

5. having serum creatinine of > 5 mg/dl or nephritic syndrome;

6. having active cellulites, severe varicose veins, lymphedema or deep vein thrombosis
over lower extremity;

7. undergoing dialysis within 2 weeks;

8. having severe coronary artery disease without complete revascularization therapy; and

9. being pregnant.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

hospitalization (cardiac and non-cardiac) and death (cardiac and non-cardiac).

Outcome Description:

Cardiac outcomes will be collected if there is any visiting emergency department due to hospitalization (cardiac and non-cardiac), and death (cardiac and non-cardiac). These visits will be recorded by telephone interview, our systemic review function of our computer system, or patient visiting.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Chang Gung Memorial Hospital


Taiwan: Institutional Review Board

Study ID:




Start Date:

June 2009

Completion Date:

August 2011

Related Keywords:

  • Death
  • Congestive Heart Failure
  • Congestive heart failure (CHF)
  • CHF education
  • self-care training
  • CHF center
  • Heart Failure