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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01416285
Enrollment
470
Registered
2011-08-15
Start date
2010-06-01
Completion date
2012-05-30
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure, Death

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

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frameDescription
All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations2 yearFollow-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

ArmCount
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
Total349

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studyowing to the care model or moving to other cities of the country09

Baseline characteristics

CharacteristicControl GroupTotalCase Management Group
Age, Continuous61.5 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 Index25.3 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 peptide637 pg/ml
STANDARD_DEVIATION 756
646 pg/ml
STANDARD_DEVIATION 742
653 pg/ml
STANDARD_DEVIATION 738
Cause
Idiopathic
36 Participants65 Participants29 Participants
Cause
Ischemic
85 Participants176 Participants91 Participants
Cause
Living alone
58 Participants114 Participants56 Participants
Cause
Valvular
27 Participants50 Participants23 Participants
Co-morbidity
Atrial Fibrillation
49 Participants96 Participants47 Participants
Co-morbidity
Chronic Kidney Disease
49 Participants91 Participants42 Participants
Co-morbidity
Chronic Obstructive Pulmonary Disease
17 Participants38 Participants21 Participants
Co-morbidity
Diabetes mellitus
82 Participants148 Participants66 Participants
Co-morbidity
Hypertension
116 Participants226 Participants110 Participants
Estimated glomerular filtration rate69.1 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 rate79.7 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 Fraction35.1 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 Participants275 Participants135 Participants
Medication
Beta-Blocker
78 Participants159 Participants81 Participants
Medication
Digoxin
49 Participants98 Participants49 Participants
Medication
Diuretic
112 Participants206 Participants94 Participants
New York Heart Association functional class
II
34 Participants68 Participants34 Participants
New York Heart Association functional class
III
130 Participants264 Participants134 Participants
New York Heart Association functional class
IV
11 Participants17 Participants6 Participants
Previous hospitalization due to Heart Failure70 Participants125 Participants55 Participants
QRS complex102.2 msec
STANDARD_DEVIATION 26.6
102.9 msec
STANDARD_DEVIATION 24.5
103.5 msec
STANDARD_DEVIATION 25.1
Race and Ethnicity Not Collected0 Participants
Serum sodium138.6 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 Participants105 Participants47 Participants
Sex: Female, Male
Male
117 Participants244 Participants127 Participants
Total bilirubin1.1 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
36 / 17515 / 165
other
Total, other adverse events
0 / 1750 / 165
serious
Total, serious adverse events
41 / 17518 / 165

Outcome results

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.

Time frame: 2 year

Population: Death, HF-related rehospitalization, and composite of death and HF-related rehospitalization

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Control GroupAll-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizationsDeath36 Participants
Control GroupAll-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizationsHeart Failure-related re-hospitalization41 Participants
Control GroupAll-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizationsDeath and Heart Failure-related re-hospitalization63 Participants
Case Management GroupAll-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizationsDeath15 Participants
Case Management GroupAll-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizationsHeart Failure-related re-hospitalization18 Participants
Case Management GroupAll-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizationsDeath and Heart Failure-related re-hospitalization28 Participants
Comparison: All-cause deathp-value: 0.004Kaplan-Meier and COX regression
Comparison: Heart failure-related re-hospitalizationsp-value: 0.003Kaplan-Meier and COX regression
Comparison: a composite outcome of both death and heart failure-related re-hospitalizationsp-value: <0.001Kaplan-Meier and COX regression

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026