Trial Outcomes & Findings for Impact of Heart Failure Center Program on Cardiac Outcomes in Patients With Heart Failure (NCT NCT01416285)
NCT ID: NCT01416285
Last Updated: 2024-03-08
Results Overview
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.
COMPLETED
470 participants
2 year
2024-03-08
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
174
|
|
Overall Study
COMPLETED
|
175
|
165
|
|
Overall Study
NOT COMPLETED
|
0
|
9
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
owing to the care model or moving to other cities of the country
|
0
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=175 Participants
control group receiving regular education from a nurse
|
Case Management Group
n=174 Participants
This is the study group. Extensive education and case management program will be performed in this group.
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 12.6 • n=175 Participants
|
59.2 years
STANDARD_DEVIATION 13.6 • n=174 Participants
|
60.3 years
STANDARD_DEVIATION 13.2 • n=349 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=175 Participants
|
47 Participants
n=174 Participants
|
105 Participants
n=349 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=175 Participants
|
127 Participants
n=174 Participants
|
244 Participants
n=349 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Previous hospitalization due to Heart Failure
|
70 Participants
n=175 Participants
|
55 Participants
n=174 Participants
|
125 Participants
n=349 Participants
|
|
New York Heart Association functional class
II
|
34 Participants
n=175 Participants
|
34 Participants
n=174 Participants
|
68 Participants
n=349 Participants
|
|
New York Heart Association functional class
III
|
130 Participants
n=175 Participants
|
134 Participants
n=174 Participants
|
264 Participants
n=349 Participants
|
|
New York Heart Association functional class
IV
|
11 Participants
n=175 Participants
|
6 Participants
n=174 Participants
|
17 Participants
n=349 Participants
|
|
Left Ventricular Ejection Fraction
|
35.1 percentage of blood ejected
STANDARD_DEVIATION 14.3 • n=175 Participants
|
36.9 percentage of blood ejected
STANDARD_DEVIATION 15.8 • n=174 Participants
|
36.0 percentage of blood ejected
STANDARD_DEVIATION 15.1 • n=349 Participants
|
|
Blood Pressure
Systolic
|
122.9 mmHg
STANDARD_DEVIATION 21.9 • n=175 Participants
|
123 mmHg
STANDARD_DEVIATION 18.2 • n=174 Participants
|
122.9 mmHg
STANDARD_DEVIATION 20.1 • n=349 Participants
|
|
Blood Pressure
Diastolic
|
73.4 mmHg
STANDARD_DEVIATION 14.3 • n=175 Participants
|
75.3 mmHg
STANDARD_DEVIATION 12.3 • n=174 Participants
|
74.3 mmHg
STANDARD_DEVIATION 13.4 • n=349 Participants
|
|
Co-morbidity
Diabetes mellitus
|
82 Participants
n=175 Participants
|
66 Participants
n=174 Participants
|
148 Participants
n=349 Participants
|
|
Co-morbidity
Chronic Kidney Disease
|
49 Participants
n=175 Participants
|
42 Participants
n=174 Participants
|
91 Participants
n=349 Participants
|
|
Co-morbidity
Hypertension
|
116 Participants
n=175 Participants
|
110 Participants
n=174 Participants
|
226 Participants
n=349 Participants
|
|
Co-morbidity
Atrial Fibrillation
|
49 Participants
n=175 Participants
|
47 Participants
n=174 Participants
|
96 Participants
n=349 Participants
|
|
Co-morbidity
Chronic Obstructive Pulmonary Disease
|
17 Participants
n=175 Participants
|
21 Participants
n=174 Participants
|
38 Participants
n=349 Participants
|
|
Cause
Ischemic
|
85 Participants
n=175 Participants
|
91 Participants
n=174 Participants
|
176 Participants
n=349 Participants
|
|
Cause
Valvular
|
27 Participants
n=175 Participants
|
23 Participants
n=174 Participants
|
50 Participants
n=349 Participants
|
|
Cause
Idiopathic
|
36 Participants
n=175 Participants
|
29 Participants
n=174 Participants
|
65 Participants
n=349 Participants
|
|
Cause
Living alone
|
58 Participants
n=175 Participants
|
56 Participants
n=174 Participants
|
114 Participants
n=349 Participants
|
|
Body Mass Index
|
25.3 kg/m^2
STANDARD_DEVIATION 5.7 • n=175 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 5 • n=174 Participants
|
25.2 kg/m^2
STANDARD_DEVIATION 5.4 • n=349 Participants
|
|
Medication
Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker
|
140 Participants
n=175 Participants
|
135 Participants
n=174 Participants
|
275 Participants
n=349 Participants
|
|
Medication
Beta-Blocker
|
78 Participants
n=175 Participants
|
81 Participants
n=174 Participants
|
159 Participants
n=349 Participants
|
|
Medication
Digoxin
|
49 Participants
n=175 Participants
|
49 Participants
n=174 Participants
|
98 Participants
n=349 Participants
|
|
Medication
Diuretic
|
112 Participants
n=175 Participants
|
94 Participants
n=174 Participants
|
206 Participants
n=349 Participants
|
|
Laboratory values
Hemoglobin
|
13.3 g/dl
STANDARD_DEVIATION 2.1 • n=175 Participants
|
13.7 g/dl
STANDARD_DEVIATION 2 • n=174 Participants
|
13.5 g/dl
STANDARD_DEVIATION 3.6 • n=349 Participants
|
|
Laboratory values
Albumin
|
3.5 g/dl
STANDARD_DEVIATION 0.5 • n=175 Participants
|
3.6 g/dl
STANDARD_DEVIATION 0.5 • n=174 Participants
|
3.6 g/dl
STANDARD_DEVIATION 0.5 • n=349 Participants
|
|
Heart rate
|
79.7 beats/min
STANDARD_DEVIATION 14.7 • n=175 Participants
|
77.7 beats/min
STANDARD_DEVIATION 11.7 • n=174 Participants
|
78.7 beats/min
STANDARD_DEVIATION 13.3 • n=349 Participants
|
|
Estimated glomerular filtration rate
|
69.1 ml/min/1.73m^2
STANDARD_DEVIATION 36.1 • n=175 Participants
|
74.7 ml/min/1.73m^2
STANDARD_DEVIATION 23.8 • n=174 Participants
|
71.8 ml/min/1.73m^2
STANDARD_DEVIATION 30.6 • n=349 Participants
|
|
B-type natriuretic peptide
|
637 pg/ml
STANDARD_DEVIATION 756 • n=175 Participants
|
653 pg/ml
STANDARD_DEVIATION 738 • n=174 Participants
|
646 pg/ml
STANDARD_DEVIATION 742 • n=349 Participants
|
|
Serum sodium
|
138.6 mEq/l
STANDARD_DEVIATION 3.4 • n=175 Participants
|
138.9 mEq/l
STANDARD_DEVIATION 3.8 • n=174 Participants
|
138.7 mEq/l
STANDARD_DEVIATION 3.6 • n=349 Participants
|
|
Total bilirubin
|
1.1 mg/dl
STANDARD_DEVIATION 0.6 • n=175 Participants
|
1.1 mg/dl
STANDARD_DEVIATION 0.7 • n=174 Participants
|
1.1 mg/dl
STANDARD_DEVIATION 0.7 • n=349 Participants
|
|
QRS complex
|
102.2 msec
STANDARD_DEVIATION 26.6 • n=175 Participants
|
103.5 msec
STANDARD_DEVIATION 25.1 • n=174 Participants
|
102.9 msec
STANDARD_DEVIATION 24.5 • n=349 Participants
|
PRIMARY outcome
Timeframe: 2 yearPopulation: Death, HF-related rehospitalization, and composite of death and HF-related rehospitalization
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.
Outcome measures
| Measure |
Control Group
n=175 Participants
control group receiving regular education from a nurse
|
Case Management Group
n=165 Participants
This is the study group. Extensive education and case management program will be performed in this 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
|
15 Participants
|
|
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
|
18 Participants
|
|
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
|
28 Participants
|
Adverse Events
Control Group
Case Management Group
Serious adverse events
| Measure |
Control Group
n=175 participants at risk
control group receiving regular education from a nurse
|
Case Management Group
n=165 participants at risk
This is the study group. Extensive education and case management program will be performed in this group.
|
|---|---|---|
|
Cardiac disorders
Heart failure-related re-hospitalizations
|
23.4%
41/175 • Number of events 41 • 2 year
|
10.9%
18/165 • Number of events 18 • 2 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place