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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01416285
First received: August 11, 2011
Last updated: August 12, 2011
Last verified: July 2011
  Purpose

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.


Condition
Death
Congestive Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • hospitalization (cardiac and non-cardiac) and death (cardiac and non-cardiac). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

At baseline and every 6-month visits, 3 ml of venous blood will be collected. At baseline and each 6-month visit, urinary albumin amount will be measured in the core lab in the hospital.


Estimated Enrollment: 300
Study Start Date: June 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
control group
control group receiving regular education from a nurse
Case management group
This is the study group. Extensive education and case management program will be performed in this group.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416285

Contacts
Contact: CHAO-HUNG WANG, MD +886-2-24313131 ext 3168 bearty54@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Keelung, Taiwan, 402
Contact: CHAO-HUNG WANG, MD    +886-2-24313131 ext 3168    bearty54@gmail.com   
Principal Investigator: CHAO-HUNG WANG, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: CHAO-HUNG WANG, MD Chang Gung Memorial Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tsang-Tang Hsieh, CHANG GUNG MEORIAL HOSPITAL
ClinicalTrials.gov Identifier: NCT01416285     History of Changes
Other Study ID Numbers: 98-1154B, CMRPG280251
Study First Received: August 11, 2011
Last Updated: August 12, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Congestive heart failure (CHF)
CHF education
self-care training
CHF center

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014