Trial Outcomes & Findings for Optimization of the Ambulatory Monitoring for Patients With Heart Failure by Tele-cardiology (NCT NCT02068118)
NCT ID: NCT02068118
Last Updated: 2021-10-26
Results Overview
Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
990 participants
Primary outcome timeframe
18 months
Results posted on
2021-10-26
Participant Flow
Between May 13, 2013 and June 22, 2016, 990 patients were enrolled at 38 French centers. Last patient completed 18-month comparative period on December 20, 2017. After this 18-month period, 20 patients entered the non-comparative extension period between June 1, 2017 and March 27, 2018. Last patient completed extension period on September 28, 2018.
Participant milestones
| Measure |
Standard Care
* Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.
* Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.
|
Tele-cardiology Group
Device: Telecardiology Program
\- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
\- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period.
|
|---|---|---|
|
18-month Comparative Study Period
STARTED
|
455
|
482
|
|
18-month Comparative Study Period
COMPLETED
|
327
|
305
|
|
18-month Comparative Study Period
NOT COMPLETED
|
128
|
177
|
|
Extension Period
STARTED
|
7
|
13
|
|
Extension Period
COMPLETED
|
5
|
10
|
|
Extension Period
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Standard Care
* Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.
* Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.
|
Tele-cardiology Group
Device: Telecardiology Program
\- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
\- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period.
|
|---|---|---|
|
18-month Comparative Study Period
Death
|
90
|
97
|
|
18-month Comparative Study Period
Withdrawal by Subject
|
23
|
52
|
|
18-month Comparative Study Period
Lost to Follow-up
|
6
|
7
|
|
18-month Comparative Study Period
Heart transplant
|
9
|
15
|
|
18-month Comparative Study Period
Inclusion in another protocol
|
0
|
2
|
|
18-month Comparative Study Period
Hemiplegia
|
0
|
1
|
|
18-month Comparative Study Period
Alzheimer's disease
|
0
|
1
|
|
18-month Comparative Study Period
Move
|
0
|
1
|
|
18-month Comparative Study Period
Hearing loss
|
0
|
1
|
|
Extension Period
Death
|
0
|
2
|
|
Extension Period
Withdrawal by Subject
|
1
|
0
|
|
Extension Period
Heart transplant
|
1
|
0
|
|
Extension Period
Wrong device use
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Care
n=455 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=482 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
Total
n=937 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 12.5 • n=455 Participants
|
70.0 years
STANDARD_DEVIATION 12.4 • n=482 Participants
|
69.9 years
STANDARD_DEVIATION 12.4 • n=937 Participants
|
|
Age, Customized
< 60 years
|
105 Participants
n=455 Participants
|
93 Participants
n=482 Participants
|
198 Participants
n=937 Participants
|
|
Age, Customized
≥ 60 and < 80 years
|
237 Participants
n=455 Participants
|
268 Participants
n=482 Participants
|
505 Participants
n=937 Participants
|
|
Age, Customized
≥ 80 years
|
113 Participants
n=455 Participants
|
121 Participants
n=482 Participants
|
234 Participants
n=937 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=455 Participants
|
128 Participants
n=482 Participants
|
260 Participants
n=937 Participants
|
|
Sex: Female, Male
Male
|
323 Participants
n=455 Participants
|
354 Participants
n=482 Participants
|
677 Participants
n=937 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
455 Participants
n=455 Participants
|
482 Participants
n=482 Participants
|
937 Participants
n=937 Participants
|
|
NYHA classification
I
|
32 Participants
n=452 Participants • Difference from the overall number of baseline participants due to missing data.
|
29 Participants
n=475 Participants • Difference from the overall number of baseline participants due to missing data.
|
61 Participants
n=927 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
NYHA classification
II
|
196 Participants
n=452 Participants • Difference from the overall number of baseline participants due to missing data.
|
210 Participants
n=475 Participants • Difference from the overall number of baseline participants due to missing data.
|
406 Participants
n=927 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
NYHA classification
III
|
185 Participants
n=452 Participants • Difference from the overall number of baseline participants due to missing data.
|
182 Participants
n=475 Participants • Difference from the overall number of baseline participants due to missing data.
|
367 Participants
n=927 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
NYHA classification
IV
|
39 Participants
n=452 Participants • Difference from the overall number of baseline participants due to missing data.
|
54 Participants
n=475 Participants • Difference from the overall number of baseline participants due to missing data.
|
93 Participants
n=927 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Cardiopathy
Ischemic
|
211 Participants
n=454 Participants • Difference from the overall number of baseline participants due to missing data.
|
232 Participants
n=481 Participants • Difference from the overall number of baseline participants due to missing data.
|
443 Participants
n=935 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Cardiopathy
Non Ischemic
|
243 Participants
n=454 Participants • Difference from the overall number of baseline participants due to missing data.
|
249 Participants
n=481 Participants • Difference from the overall number of baseline participants due to missing data.
|
492 Participants
n=935 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Heart failure
Left
|
184 Participants
n=453 Participants • Difference from the overall number of baseline participants due to missing data.
|
185 Participants
n=480 Participants • Difference from the overall number of baseline participants due to missing data.
|
369 Participants
n=933 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Heart failure
Right
|
34 Participants
n=453 Participants • Difference from the overall number of baseline participants due to missing data.
|
24 Participants
n=480 Participants • Difference from the overall number of baseline participants due to missing data.
|
58 Participants
n=933 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Heart failure
Global
|
235 Participants
n=453 Participants • Difference from the overall number of baseline participants due to missing data.
|
271 Participants
n=480 Participants • Difference from the overall number of baseline participants due to missing data.
|
506 Participants
n=933 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Left Ventricular Ejection Fraction (LVEF)
|
38.1 Percentage
STANDARD_DEVIATION 15.2 • n=455 Participants • Difference from the overall number of baseline participants due to missing data.
|
39.3 Percentage
STANDARD_DEVIATION 14.5 • n=479 Participants • Difference from the overall number of baseline participants due to missing data.
|
38.7 Percentage
STANDARD_DEVIATION 14.9 • n=934 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Left Ventricular Ejection Fraction (LVEF), categorical
≤ 40%
|
280 Participants
n=455 Participants • Difference from the overall number of baseline participants due to missing data.
|
280 Participants
n=479 Participants • Difference from the overall number of baseline participants due to missing data.
|
560 Participants
n=934 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Left Ventricular Ejection Fraction (LVEF), categorical
> 40% and ≤ 50%
|
89 Participants
n=455 Participants • Difference from the overall number of baseline participants due to missing data.
|
95 Participants
n=479 Participants • Difference from the overall number of baseline participants due to missing data.
|
184 Participants
n=934 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Left Ventricular Ejection Fraction (LVEF), categorical
> 50%
|
86 Participants
n=455 Participants • Difference from the overall number of baseline participants due to missing data.
|
104 Participants
n=479 Participants • Difference from the overall number of baseline participants due to missing data.
|
190 Participants
n=934 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
BNP
|
484 pg/mL
n=191 Participants • Difference from the overall number of baseline participants due to missing data and assay of either BNP or NT pro BNP for each participant.
|
510 pg/mL
n=211 Participants • Difference from the overall number of baseline participants due to missing data and assay of either BNP or NT pro BNP for each participant.
|
501 pg/mL
n=402 Participants • Difference from the overall number of baseline participants due to missing data and assay of either BNP or NT pro BNP for each participant.
|
|
NT-pro-BNP
|
3277 pg/mL
n=265 Participants • Difference from the overall number of baseline participants due to missing data and assay of either NT pro BNP or BNP for each participant.
|
3519 pg/mL
n=269 Participants • Difference from the overall number of baseline participants due to missing data and assay of either NT pro BNP or BNP for each participant.
|
3379 pg/mL
n=534 Participants • Difference from the overall number of baseline participants due to missing data and assay of either NT pro BNP or BNP for each participant.
|
|
Previous participation in an ETP
Yes
|
114 Participants
n=455 Participants
|
109 Participants
n=482 Participants
|
223 Participants
n=937 Participants
|
|
Previous participation in an ETP
No
|
341 Participants
n=455 Participants
|
373 Participants
n=482 Participants
|
714 Participants
n=937 Participants
|
|
Arterial hypertension
Yes
|
246 Participants
n=455 Participants
|
296 Participants
n=482 Participants
|
542 Participants
n=937 Participants
|
|
Arterial hypertension
No
|
209 Participants
n=455 Participants
|
186 Participants
n=482 Participants
|
395 Participants
n=937 Participants
|
|
Dyslipidemia
Yes
|
248 Participants
n=455 Participants
|
269 Participants
n=482 Participants
|
517 Participants
n=937 Participants
|
|
Dyslipidemia
No
|
207 Participants
n=455 Participants
|
213 Participants
n=482 Participants
|
420 Participants
n=937 Participants
|
|
Family History of Cardiovascular Disease
Yes
|
73 Participants
n=455 Participants
|
109 Participants
n=482 Participants
|
182 Participants
n=937 Participants
|
|
Family History of Cardiovascular Disease
No
|
382 Participants
n=455 Participants
|
373 Participants
n=482 Participants
|
755 Participants
n=937 Participants
|
|
Obesity
Yes
|
122 Participants
n=455 Participants
|
140 Participants
n=482 Participants
|
262 Participants
n=937 Participants
|
|
Obesity
No
|
333 Participants
n=455 Participants
|
342 Participants
n=482 Participants
|
675 Participants
n=937 Participants
|
|
Smoking
Yes
|
116 Participants
n=455 Participants
|
111 Participants
n=482 Participants
|
227 Participants
n=937 Participants
|
|
Smoking
No
|
339 Participants
n=455 Participants
|
371 Participants
n=482 Participants
|
710 Participants
n=937 Participants
|
|
Coronary heart disease
Yes
|
228 Participants
n=455 Participants
|
236 Participants
n=482 Participants
|
464 Participants
n=937 Participants
|
|
Coronary heart disease
No
|
227 Participants
n=455 Participants
|
246 Participants
n=482 Participants
|
473 Participants
n=937 Participants
|
|
Diabetes mellitus
Yes
|
161 Participants
n=455 Participants
|
146 Participants
n=482 Participants
|
307 Participants
n=937 Participants
|
|
Diabetes mellitus
No
|
294 Participants
n=455 Participants
|
336 Participants
n=482 Participants
|
630 Participants
n=937 Participants
|
|
Chronic renal disease
Yes
|
128 Participants
n=455 Participants • Difference from the overall number of baseline participants due to missing data.
|
129 Participants
n=481 Participants • Difference from the overall number of baseline participants due to missing data.
|
257 Participants
n=936 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Chronic renal disease
No
|
327 Participants
n=455 Participants • Difference from the overall number of baseline participants due to missing data.
|
352 Participants
n=481 Participants • Difference from the overall number of baseline participants due to missing data.
|
679 Participants
n=936 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Chronic Obstructive Pulmonary Disease
Yes
|
89 Participants
n=455 Participants
|
89 Participants
n=482 Participants
|
178 Participants
n=937 Participants
|
|
Chronic Obstructive Pulmonary Disease
No
|
366 Participants
n=455 Participants
|
393 Participants
n=482 Participants
|
759 Participants
n=937 Participants
|
|
Implantable cardioverter-defibrillator
Yes
|
60 Participants
n=455 Participants
|
60 Participants
n=482 Participants
|
120 Participants
n=937 Participants
|
|
Implantable cardioverter-defibrillator
No
|
395 Participants
n=455 Participants
|
422 Participants
n=482 Participants
|
817 Participants
n=937 Participants
|
|
Cardiac resynchronization therapy
Yes
|
1 Participants
n=455 Participants
|
0 Participants
n=482 Participants
|
1 Participants
n=937 Participants
|
|
Cardiac resynchronization therapy
No
|
454 Participants
n=455 Participants
|
482 Participants
n=482 Participants
|
936 Participants
n=937 Participants
|
|
Loop diuretics
Yes
|
417 Participants
n=455 Participants
|
447 Participants
n=482 Participants
|
864 Participants
n=937 Participants
|
|
Loop diuretics
No
|
38 Participants
n=455 Participants
|
35 Participants
n=482 Participants
|
73 Participants
n=937 Participants
|
|
Beta-blockers
Yes
|
367 Participants
n=455 Participants
|
379 Participants
n=482 Participants
|
746 Participants
n=937 Participants
|
|
Beta-blockers
No
|
88 Participants
n=455 Participants
|
103 Participants
n=482 Participants
|
191 Participants
n=937 Participants
|
|
ACE inhibitors or ARBs
Yes
|
345 Participants
n=455 Participants
|
354 Participants
n=482 Participants
|
699 Participants
n=937 Participants
|
|
ACE inhibitors or ARBs
No
|
110 Participants
n=455 Participants
|
128 Participants
n=482 Participants
|
238 Participants
n=937 Participants
|
|
Aldosterone antagonists
Yes
|
211 Participants
n=455 Participants
|
220 Participants
n=482 Participants
|
431 Participants
n=937 Participants
|
|
Aldosterone antagonists
No
|
244 Participants
n=455 Participants
|
262 Participants
n=482 Participants
|
506 Participants
n=937 Participants
|
|
Ivabradine
Yes
|
37 Participants
n=453 Participants • Difference from the overall number of baseline participants due to missing data.
|
23 Participants
n=479 Participants • Difference from the overall number of baseline participants due to missing data.
|
60 Participants
n=932 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Ivabradine
No
|
416 Participants
n=453 Participants • Difference from the overall number of baseline participants due to missing data.
|
456 Participants
n=479 Participants • Difference from the overall number of baseline participants due to missing data.
|
872 Participants
n=932 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Digoxin
Yes
|
15 Participants
n=454 Participants • Difference from the overall number of baseline participants due to missing data.
|
28 Participants
n=481 Participants • Difference from the overall number of baseline participants due to missing data.
|
43 Participants
n=935 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Digoxin
No
|
439 Participants
n=454 Participants • Difference from the overall number of baseline participants due to missing data.
|
453 Participants
n=481 Participants • Difference from the overall number of baseline participants due to missing data.
|
892 Participants
n=935 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Glomerular Filtration Rate (GFR)
|
60.6 mL/min
STANDARD_DEVIATION 25.1 • n=455 Participants • Difference from the overall number of baseline participants due to missing data.
|
60.5 mL/min
STANDARD_DEVIATION 25.5 • n=478 Participants • Difference from the overall number of baseline participants due to missing data.
|
60.5 mL/min
STANDARD_DEVIATION 25.3 • n=933 Participants • Difference from the overall number of baseline participants due to missing data.
|
|
Weight
|
77.2 kg
STANDARD_DEVIATION 17.8 • n=455 Participants
|
79.3 kg
STANDARD_DEVIATION 18.2 • n=482 Participants
|
78.3 kg
STANDARD_DEVIATION 18.0 • n=937 Participants
|
|
Body Mass Index (BMI)
|
27.1 kg/m²
STANDARD_DEVIATION 5.5 • n=455 Participants
|
27.6 kg/m²
STANDARD_DEVIATION 6.0 • n=482 Participants
|
27.4 kg/m²
STANDARD_DEVIATION 5.8 • n=937 Participants
|
|
Supine systolic blood pressure
|
118.9 mmHg
STANDARD_DEVIATION 19.3 • n=455 Participants
|
119.6 mmHg
STANDARD_DEVIATION 19.9 • n=482 Participants
|
119.3 mmHg
STANDARD_DEVIATION 19.6 • n=937 Participants
|
|
Supine diastolic blood pressure
|
69.5 mmHg
STANDARD_DEVIATION 12.2 • n=455 Participants
|
69.9 mmHg
STANDARD_DEVIATION 11.2 • n=482 Participants
|
69.7 mmHg
STANDARD_DEVIATION 11.7 • n=937 Participants
|
|
Supine pulse rate
|
72.7 beats/min
STANDARD_DEVIATION 13.9 • n=455 Participants • Difference from the overall number of baseline participants due to missing data.
|
73.7 beats/min
STANDARD_DEVIATION 15.4 • n=481 Participants • Difference from the overall number of baseline participants due to missing data.
|
73.2 beats/min
STANDARD_DEVIATION 14.7 • n=936 Participants • Difference from the overall number of baseline participants due to missing data.
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: ITT population
Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)
Outcome measures
| Measure |
Standard Care
n=455 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=482 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Number of All Causes Deaths and (Unplanned) Hospitalizations
|
1.46 Events
Standard Deviation 1.98
|
1.30 Events
Standard Deviation 1.85
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: ITT population with New York Heart Association (NYHA) class III or IV at inclusion (N=460 patients)
Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)
Outcome measures
| Measure |
Standard Care
n=224 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=236 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Number of All Causes Deaths and (Unplanned) Hospitalizations in NYHA Class III or IV Patients
|
1.99 Events
Standard Deviation 2.26
|
1.53 Events
Standard Deviation 1.98
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: ITT population with socially isolated status at inclusion (N=216 patients) defined as: either i) SF-36 Mental Health score \<45; or ii) Mental Component Summary score \<35; or iii) combination of Mental Health score \<50 plus Mental Component Summary score \<40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications
Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)
Outcome measures
| Measure |
Standard Care
n=104 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=112 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Number of All Causes Deaths and (Unplanned) Hospitalizations in Socially Isolated Patients
|
1.89 Events
Standard Deviation 2.14
|
1.30 Events
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: ITT population
Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned
Outcome measures
| Measure |
Standard Care
n=254 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=255 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Time to First Unplanned Hospital Readmission or Death From Any Cause
|
84 days
Interval 29.0 to 238.0
|
105 days
Interval 30.0 to 232.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: ITT population
Number of patients who died from any cause
Outcome measures
| Measure |
Standard Care
n=455 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=482 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
All Causes Deaths - Number of Patients Who Died From Any Cause
|
89 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: ITT population
Time to death from any cause in the subgroup of patients who died
Outcome measures
| Measure |
Standard Care
n=89 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=91 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Time to Death From Any Cause
|
233 days
Interval 100.0 to 390.0
|
252 days
Interval 148.0 to 369.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: ITT population
Number of unplanned hospitalizations for any cause (adjudicated events)
Outcome measures
| Measure |
Standard Care
n=455 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=482 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Number of Unplanned Hospitalizations for Any Cause
|
1.27 Events
Standard Deviation 1.82
|
1.11 Events
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: ITT population
Composite morbidity-mortality criterion combining the number of cardiovascular unplanned hospitalizations and deaths from cardiovascular cause (adjudicated events)
Outcome measures
| Measure |
Standard Care
n=455 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=482 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Number of Deaths and Unplanned Hospitalizations From Cardiovascular Cause
|
1.07 Events
Standard Deviation 1.75
|
0.96 Events
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: ITT population
Number of unplanned hospitalizations for heart failure (adjudicated events)
Outcome measures
| Measure |
Standard Care
n=455 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=482 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Number of Unplanned Hospitalizations for Heart Failure
|
0.75 Events
Standard Deviation 1.42
|
0.59 Events
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: ITT population with New York Heart Association (NYHA) class III or IV at inclusion (N=460 patients)
Number of unplanned hospitalizations for heart failure (adjudicated events)
Outcome measures
| Measure |
Standard Care
n=224 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=236 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Number of Unplanned Hospitalizations for Heart Failure in NYHA Class III or IV Patients
|
1.02 Events
Standard Deviation 1.68
|
0.70 Events
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: ITT population with socially isolated status at inclusion (N=216 patients) defined as: either i) SF-36 Mental Health score \<45; or ii) Mental Component Summary score \<35; or iii) combination of Mental Health score \<50 plus Mental Component Summary score \<40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications
Number of unplanned hospitalizations for heart failure (adjudicated events)
Outcome measures
| Measure |
Standard Care
n=104 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=112 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Number of Unplanned Hospitalizations for Heart Failure in Socially Isolated Patients
|
1.00 Events
Standard Deviation 1.61
|
0.58 Events
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: ITT population
Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned
Outcome measures
| Measure |
Standard Care
n=160 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=141 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Time to First Unplanned Hospital Readmission for Heart Failure
|
79 days
Interval 28.0 to 236.0
|
97 days
Interval 32.0 to 252.0
|
SECONDARY outcome
Timeframe: Between baseline and 12 months and between baseline and 18 monthsPopulation: ITT population
Evolution of Quality of Life assessed using absolute changes from baseline of each dimension and both component summary scores of SF-36 questionnaire. Indeed, SF-36 questionnaire include 8 general dimensions and 2 composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). They are standardized to range between 0 and 100. Higher scores on all SF-36 scales indicate more favorable levels of functioning and less disability. Thus, higher Physical Functioning scores reflect higher physical functioning. Higher Role Physical scores reflect lower limitations due to physical problems. Higher Bodily Pain scores reflect less bodily pain. Higher General Health scores reflect higher general health perception. Higher Vitality scores reflect higher vitality. Higher Social Functioning scores reflect higher social functioning. Higher Role Emotional scores reflect lower limitations due to emotional problems. Higher Mental Health scores reflect better mental health.
Outcome measures
| Measure |
Standard Care
n=323 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=307 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Physical Component Summary - 18 Months
|
2.9 score on a scale
Standard Deviation 10.6
|
3.2 score on a scale
Standard Deviation 10.7
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Physical Functioning - 12 months
|
-1.3 score on a scale
Standard Deviation 27.3
|
0.0 score on a scale
Standard Deviation 28.0
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Physical Functioning - 18 months
|
2.4 score on a scale
Standard Deviation 26.3
|
1.3 score on a scale
Standard Deviation 28.3
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Role Physical - 12 Months
|
12.5 score on a scale
Standard Deviation 48.0
|
12.5 score on a scale
Standard Deviation 48.0
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Role Physical - 18 Months
|
20.5 score on a scale
Standard Deviation 40.2
|
20.7 score on a scale
Standard Deviation 41.1
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Bodily Pain - 12 Months
|
1.9 score on a scale
Standard Deviation 38.8
|
4.1 score on a scale
Standard Deviation 36.9
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Bodily Pain - 18 Months
|
0.6 score on a scale
Standard Deviation 35.8
|
4.6 score on a scale
Standard Deviation 33.6
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
General Health - 12 Months
|
0.4 score on a scale
Standard Deviation 21.7
|
3.4 score on a scale
Standard Deviation 22.3
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
General Health - 18 Months
|
5.2 score on a scale
Standard Deviation 20.4
|
6.8 score on a scale
Standard Deviation 22.5
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Vitality - 12 Months
|
5.7 score on a scale
Standard Deviation 22.1
|
9.0 score on a scale
Standard Deviation 23.7
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Vitality - 18 Months
|
7.3 score on a scale
Standard Deviation 21.7
|
11.1 score on a scale
Standard Deviation 21.8
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Social Functioning - 12 Months
|
-0.3 score on a scale
Standard Deviation 35.5
|
4.4 score on a scale
Standard Deviation 33.8
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Social Functioning - 18 Months
|
3.2 score on a scale
Standard Deviation 33.3
|
3.8 score on a scale
Standard Deviation 33.9
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Role Emotional - 12 Months
|
-4.3 score on a scale
Standard Deviation 45.7
|
-2.7 score on a scale
Standard Deviation 46.9
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Role Emotional - 18 Months
|
6.0 score on a scale
Standard Deviation 35.8
|
8.3 score on a scale
Standard Deviation 35.9
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Mental Health - 12 Months
|
1.6 score on a scale
Standard Deviation 19.4
|
3.9 score on a scale
Standard Deviation 18.8
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Mental Health - 18 Months
|
3.3 score on a scale
Standard Deviation 18.9
|
4.3 score on a scale
Standard Deviation 18.5
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Physical Component Summary - 12 Months
|
1.5 score on a scale
Standard Deviation 11.2
|
2.2 score on a scale
Standard Deviation 11.1
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Mental Component Summary - 12 Months
|
0.1 score on a scale
Standard Deviation 10.8
|
1.8 score on a scale
Standard Deviation 11.3
|
|
Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores
Mental Component Summary - 18 Months
|
2.0 score on a scale
Standard Deviation 10.4
|
3.1 score on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)Population: Extension Period Set
Annualized number of unplanned hospitalizations for any cause according to investigators in patients hospitalized at least once during the extension period
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=5 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Annualized Number of Unplanned Hospitalizations for Any Cause During the Extension Period
|
1.30 Events
Standard Deviation 0.57
|
3.30 Events
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)Population: Extension Period Set
Number of patients who died from any cause during the extension period
Outcome measures
| Measure |
Standard Care
n=7 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=13 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Number of Patients Who Died From Any Cause During the Extension Period
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)Population: Extension Period Set
Annualized number of unplanned hospitalizations from cardiovascular cause according to investigators in patients hospitalized at least once for cardiovascular cause during the extension period
Outcome measures
| Measure |
Standard Care
n=2 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=5 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Annualized Number of Unplanned Hospitalizations From Cardiovascular Cause During the Extension Period
|
1.30 Events
Standard Deviation 0.57
|
2.84 Events
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)Population: Extension Period Set
Number of patients who died from cardiovascular cause according to investigators during the extension period
Outcome measures
| Measure |
Standard Care
n=7 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=13 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Number of Patients Who Died From Cardiovascular Cause During the Extension Period
|
0 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: 18 monthsPopulation: New York Heart Association (NYHA) class III or IV at inclusion patients with unplanned hospital readmission or death from any cause included in the Overall Number of Participants Analyzed
Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned
Outcome measures
| Measure |
Standard Care
n=157 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=140 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Time to First Unplanned Hospital Readmission or Death From Any Cause in NYHA Class III or IV Patients
|
67 days
Interval 27.0 to 191.0
|
82 days
Interval 29.0 to 158.0
|
POST_HOC outcome
Timeframe: 18 monthsPopulation: Patients with socially isolated status at inclusion defined as: either i) SF-36 Mental Health score \<45; or ii) Mental Component Summary score \<35; or iii) combination of Mental Health score \<50 plus Mental Component Summary score \<40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications and with unplanned hospital readmission or death from any cause included in the Overall Number of Participants Analyzed'
Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned
Outcome measures
| Measure |
Standard Care
n=70 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=64 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Time to First Unplanned Hospital Readmission or Death From Any Cause in Socially Isolated Patients
|
81 days
Interval 28.0 to 240.0
|
91 days
Interval 32.0 to 277.0
|
POST_HOC outcome
Timeframe: 18 monthsPopulation: New York Heart Association (NYHA) class III or IV at inclusion patients with unplanned hospital readmission for heart failure included in the Overall Number of Participants Analyzed
Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned
Outcome measures
| Measure |
Standard Care
n=101 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=78 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Time to First Unplanned Hospital Readmission for Heart Failure in NYHA Class III or IV Patients
|
62 days
Interval 24.0 to 182.0
|
82 days
Interval 30.0 to 183.0
|
POST_HOC outcome
Timeframe: 18 monthsPopulation: Patients with socially isolated status at inclusion defined as: either i) SF-36 Mental Health score \<45; or ii) Mental Component Summary score \<35; or iii) combination of Mental Health score \<50 plus Mental Component Summary score \<40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications and with unplanned hospital readmission for heart failure included in the Overall Number of Participants Analyzed'
Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned
Outcome measures
| Measure |
Standard Care
n=47 Participants
Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists
|
Tele-cardiology Group
n=31 Participants
The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.
Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.
|
|---|---|---|
|
Time to First Unplanned Hospital Readmission for Heart Failure in Socially Isolated Patients
|
77 days
Interval 27.0 to 231.0
|
80 days
Interval 23.0 to 318.0
|
Adverse Events
Standard Care/Tele-cardiology
Serious events: 0 serious events
Other events: 0 other events
Deaths: 90 deaths
Tele-cardiology Group/Tele-cardiology
Serious events: 0 serious events
Other events: 0 other events
Deaths: 99 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release, can require changes to the communication and can embargo communications regarding trial results for a period that is less than or equal to 180 days from the time submitted to the sponsor for review. The modifications made by the sponsor cannot in any way affect the scientific value of the publication.
- Publication restrictions are in place
Restriction type: OTHER