Impact of Heart Failure Center Program on Cardiac Outcomes in Patients With Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416285
• Other study ID #: 98-1154B
• Secondary ID: CMRPG280251
• Status: Completed
• Start date: June 1, 2010
• Est. completion date: May 30, 2012

Study information

• Verified date: March 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: May 30, 2012
• Est. primary completion date: May 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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; and

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Death
• Heart Failure

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations	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.	2 year

External Links

•   European Society of Cardiology, Heart Failure association