Congestive Heart Failure, Death
Conditions
Keywords
Congestive heart failure (CHF), CHF education, self-care training, CHF center
Brief 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.
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.
Interventions
None listed
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations | 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. |
Countries
Taiwan
Participant flow
Recruitment details
The study enrolled patients consecutively hospitalized for acute or decompensated chronic heart failure in the heart failure center of Chang Gung Memorial Hospital, Keelung, Taiwan from June 1, 2010 to May 30, 2012.
Pre-assignment details
Of 470 enrolled participants, 121 were excluded (42 were excluded because of met exclusion criteria, 42 refused to participate, and 26 were excluded because of other reasons) , 349 met inclusion criteria and randomized to into the control and the case management groups.
Participants by arm
| Arm | Count |
|---|---|
| Control Group control group receiving regular education from a nurse | 175 |
| Case Management Group This is the study group. Extensive education and case management program will be performed in this group. | 174 |
| Total | 349 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | owing to the care model or moving to other cities of the country | 0 | 9 |
Baseline characteristics
| Characteristic | Control Group | Total | Case Management Group |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 12.6 | 60.3 years STANDARD_DEVIATION 13.2 | 59.2 years STANDARD_DEVIATION 13.6 |
| Blood Pressure Diastolic | 73.4 mmHg STANDARD_DEVIATION 14.3 | 74.3 mmHg STANDARD_DEVIATION 13.4 | 75.3 mmHg STANDARD_DEVIATION 12.3 |
| Blood Pressure Systolic | 122.9 mmHg STANDARD_DEVIATION 21.9 | 122.9 mmHg STANDARD_DEVIATION 20.1 | 123 mmHg STANDARD_DEVIATION 18.2 |
| Body Mass Index | 25.3 kg/m^2 STANDARD_DEVIATION 5.7 | 25.2 kg/m^2 STANDARD_DEVIATION 5.4 | 25.1 kg/m^2 STANDARD_DEVIATION 5 |
| B-type natriuretic peptide | 637 pg/ml STANDARD_DEVIATION 756 | 646 pg/ml STANDARD_DEVIATION 742 | 653 pg/ml STANDARD_DEVIATION 738 |
| Cause Idiopathic | 36 Participants | 65 Participants | 29 Participants |
| Cause Ischemic | 85 Participants | 176 Participants | 91 Participants |
| Cause Living alone | 58 Participants | 114 Participants | 56 Participants |
| Cause Valvular | 27 Participants | 50 Participants | 23 Participants |
| Co-morbidity Atrial Fibrillation | 49 Participants | 96 Participants | 47 Participants |
| Co-morbidity Chronic Kidney Disease | 49 Participants | 91 Participants | 42 Participants |
| Co-morbidity Chronic Obstructive Pulmonary Disease | 17 Participants | 38 Participants | 21 Participants |
| Co-morbidity Diabetes mellitus | 82 Participants | 148 Participants | 66 Participants |
| Co-morbidity Hypertension | 116 Participants | 226 Participants | 110 Participants |
| Estimated glomerular filtration rate | 69.1 ml/min/1.73m^2 STANDARD_DEVIATION 36.1 | 71.8 ml/min/1.73m^2 STANDARD_DEVIATION 30.6 | 74.7 ml/min/1.73m^2 STANDARD_DEVIATION 23.8 |
| Heart rate | 79.7 beats/min STANDARD_DEVIATION 14.7 | 78.7 beats/min STANDARD_DEVIATION 13.3 | 77.7 beats/min STANDARD_DEVIATION 11.7 |
| Laboratory values Albumin | 3.5 g/dl STANDARD_DEVIATION 0.5 | 3.6 g/dl STANDARD_DEVIATION 0.5 | 3.6 g/dl STANDARD_DEVIATION 0.5 |
| Laboratory values Hemoglobin | 13.3 g/dl STANDARD_DEVIATION 2.1 | 13.5 g/dl STANDARD_DEVIATION 3.6 | 13.7 g/dl STANDARD_DEVIATION 2 |
| Left Ventricular Ejection Fraction | 35.1 percentage of blood ejected STANDARD_DEVIATION 14.3 | 36.0 percentage of blood ejected STANDARD_DEVIATION 15.1 | 36.9 percentage of blood ejected STANDARD_DEVIATION 15.8 |
| Medication Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker | 140 Participants | 275 Participants | 135 Participants |
| Medication Beta-Blocker | 78 Participants | 159 Participants | 81 Participants |
| Medication Digoxin | 49 Participants | 98 Participants | 49 Participants |
| Medication Diuretic | 112 Participants | 206 Participants | 94 Participants |
| New York Heart Association functional class II | 34 Participants | 68 Participants | 34 Participants |
| New York Heart Association functional class III | 130 Participants | 264 Participants | 134 Participants |
| New York Heart Association functional class IV | 11 Participants | 17 Participants | 6 Participants |
| Previous hospitalization due to Heart Failure | 70 Participants | 125 Participants | 55 Participants |
| QRS complex | 102.2 msec STANDARD_DEVIATION 26.6 | 102.9 msec STANDARD_DEVIATION 24.5 | 103.5 msec STANDARD_DEVIATION 25.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Serum sodium | 138.6 mEq/l STANDARD_DEVIATION 3.4 | 138.7 mEq/l STANDARD_DEVIATION 3.6 | 138.9 mEq/l STANDARD_DEVIATION 3.8 |
| Sex: Female, Male Female | 58 Participants | 105 Participants | 47 Participants |
| Sex: Female, Male Male | 117 Participants | 244 Participants | 127 Participants |
| Total bilirubin | 1.1 mg/dl STANDARD_DEVIATION 0.6 | 1.1 mg/dl STANDARD_DEVIATION 0.7 | 1.1 mg/dl STANDARD_DEVIATION 0.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 36 / 175 | 15 / 165 |
| other Total, other adverse events | 0 / 175 | 0 / 165 |
| serious Total, serious adverse events | 41 / 175 | 18 / 165 |
Outcome results
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.
Time frame: 2 year
Population: Death, HF-related rehospitalization, and composite of death and HF-related rehospitalization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations | Death | 36 Participants |
| Control Group | All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations | Heart Failure-related re-hospitalization | 41 Participants |
| Control Group | All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations | Death and Heart Failure-related re-hospitalization | 63 Participants |
| Case Management Group | All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations | Death | 15 Participants |
| Case Management Group | All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations | Heart Failure-related re-hospitalization | 18 Participants |
| Case Management Group | All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations | Death and Heart Failure-related re-hospitalization | 28 Participants |