Trial Outcomes & Findings for LINK-HF2 - Remote Monitoring Analytics in Heart Failure (NCT NCT04502563)
NCT ID: NCT04502563
Last Updated: 2026-04-28
Results Overview
90-day hospitalization rate in subjects in active arm vs control arm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
176 participants
Primary outcome timeframe
90 days
Results posted on
2026-04-28
Participant Flow
Participant milestones
| Measure |
Active Arm
Subjects will undergo remote monitoring, remote monitoring data will be analyzed on a predictive platform, alerts indicating heart failure worsening shared with treating team, and algorithmic response to alerts implements.
Remote monitoring and predictive analytics: Subjects will undergo remote monitoring, remote monitoring data will be analyzed on a predictive platform, alerts indicating heart failure worsening shared with treating team, and algorithmic response to alerts implements.
|
Control
Subjects will wear a sensor, but data from the sensor will not generate alerts and will not be shared with the treating team.
Sham comparator: Subjects will wear a sensor, but data from the sensor will not generate alerts and will not be shared with the treating team.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
91
|
|
Overall Study
COMPLETED
|
80
|
91
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LINK-HF2 - Remote Monitoring Analytics in Heart Failure
Baseline characteristics by cohort
| Measure |
Active Arm
n=80 Participants
Subjects will undergo remote monitoring, remote monitoring data will be analyzed on a predictive platform, alerts indicating HF worsening shared with treating team, and algorithmic response to alerts implements.
Remote monitoring and predictive analytics: Subjects will undergo remote monitoring, remote monitoring data will be analyzed on a predictive platform, alerts indicating HF worsening shared with treating team, and algorithmic response to alerts implements.
|
Control
n=91 Participants
Subjects will wear a sensor, but data from the sensor will not generate alerts and will not be shared with the treating team.
Sham comparator: Subjects will wear a sensor, but data from the sensor will not generate alerts and will not be shared with the treating team.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 9.5 • n=9 Participants
|
72.8 years
STANDARD_DEVIATION 11.9 • n=24 Participants
|
72.6 years
STANDARD_DEVIATION 10.7 • n=23 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=9 Participants
|
88 Participants
n=24 Participants
|
165 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=9 Participants
|
16 Participants
n=24 Participants
|
37 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=9 Participants
|
71 Participants
n=24 Participants
|
127 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
6 Participants
n=24 Participants
|
7 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=9 Participants
|
85 Participants
n=24 Participants
|
162 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=23 Participants
|
|
Body Mass Index
|
31.6 Kg/m^2
STANDARD_DEVIATION 8.2 • n=9 Participants
|
31.0 Kg/m^2
STANDARD_DEVIATION 6.5 • n=24 Participants
|
31.3 Kg/m^2
STANDARD_DEVIATION 7.4 • n=23 Participants
|
|
Heart failure with reduced ejection fraction
|
47 Participants
n=9 Participants
|
59 Participants
n=24 Participants
|
106 Participants
n=23 Participants
|
|
Heart failure with preserved ejection fraction
|
33 Participants
n=9 Participants
|
32 Participants
n=24 Participants
|
65 Participants
n=23 Participants
|
|
New York Heart Association Class
I
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
New York Heart Association Class
II
|
53 Participants
n=9 Participants
|
61 Participants
n=24 Participants
|
114 Participants
n=23 Participants
|
|
New York Heart Association Class
III
|
26 Participants
n=9 Participants
|
26 Participants
n=24 Participants
|
52 Participants
n=23 Participants
|
|
New York Heart Association Class
IV
|
1 Participants
n=9 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=23 Participants
|
|
Heart Failure Etiology
Ischemic
|
43 Participants
n=9 Participants
|
48 Participants
n=24 Participants
|
91 Participants
n=23 Participants
|
|
Heart Failure Etiology
Non-ischemic
|
37 Participants
n=9 Participants
|
43 Participants
n=24 Participants
|
80 Participants
n=23 Participants
|
|
Hypertension
|
59 Participants
n=9 Participants
|
72 Participants
n=24 Participants
|
131 Participants
n=23 Participants
|
|
Hyperlipidemia
|
56 Participants
n=9 Participants
|
51 Participants
n=24 Participants
|
107 Participants
n=23 Participants
|
|
Diabetes Mellitus
|
45 Participants
n=9 Participants
|
51 Participants
n=24 Participants
|
96 Participants
n=23 Participants
|
|
Sleep Apnea
|
34 Participants
n=9 Participants
|
50 Participants
n=24 Participants
|
84 Participants
n=23 Participants
|
|
Atrial Fibrillation
|
40 Participants
n=9 Participants
|
43 Participants
n=24 Participants
|
83 Participants
n=23 Participants
|
|
Atrial Flutter
|
13 Participants
n=9 Participants
|
9 Participants
n=24 Participants
|
22 Participants
n=23 Participants
|
|
Chronic Obstructive Pulmonary Disease
|
17 Participants
n=9 Participants
|
19 Participants
n=24 Participants
|
36 Participants
n=23 Participants
|
|
Depression
|
14 Participants
n=9 Participants
|
11 Participants
n=24 Participants
|
25 Participants
n=23 Participants
|
|
Stroke
|
8 Participants
n=9 Participants
|
6 Participants
n=24 Participants
|
14 Participants
n=23 Participants
|
|
Malignancy
|
4 Participants
n=9 Participants
|
4 Participants
n=24 Participants
|
8 Participants
n=23 Participants
|
|
Peripheral Vascular Disease
|
5 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=23 Participants
|
|
Beta Blocker
|
58 Participants
n=9 Participants
|
68 Participants
n=24 Participants
|
126 Participants
n=23 Participants
|
|
Angiotensin converting enzyme/Angiotensin receptor blocker/Angiotensin receptor,neprilysin inhibitor
|
51 Participants
n=9 Participants
|
64 Participants
n=24 Participants
|
115 Participants
n=23 Participants
|
|
Aldosterone Blocker
|
44 Participants
n=9 Participants
|
44 Participants
n=24 Participants
|
88 Participants
n=23 Participants
|
|
Sodium-glucose cotransporter - 2 inhibitor
|
50 Participants
n=9 Participants
|
42 Participants
n=24 Participants
|
92 Participants
n=23 Participants
|
|
Loop Diuretics
|
68 Participants
n=9 Participants
|
76 Participants
n=24 Participants
|
144 Participants
n=23 Participants
|
|
Thiazide Diuretics
|
2 Participants
n=9 Participants
|
7 Participants
n=24 Participants
|
9 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: 90 days90-day hospitalization rate in subjects in active arm vs control arm
Outcome measures
| Measure |
Active Arm
n=80 Participants
Subjects will undergo remote monitoring, remote monitoring data will be analyzed on a predictive platform, alerts indicating HF worsening shared with treating team, and algorithmic response to alerts implements.
Remote monitoring and predictive analytics: Subjects will undergo remote monitoring, remote monitoring data will be analyzed on a predictive platform, alerts indicating HF worsening shared with treating team, and algorithmic response to alerts implements.
|
Control
n=91 Participants
Subjects will wear a sensor, but data from the sensor will not generate alerts and will not be shared with the treating team.
Sham comparator: Subjects will wear a sensor, but data from the sensor will not generate alerts and will not be shared with the treating team.
|
|---|---|---|
|
Heart Failure Hospitalization Rate
|
13 Heart failure hospitalizations
|
16 Heart failure hospitalizations
|
SECONDARY outcome
Timeframe: 90 daysScale range 0-100. Higher result is better.
Outcome measures
Outcome data not reported
Adverse Events
Active Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Josef Stehlik, MD, MPH
VA Salt Lake City Health Care System
Phone: (801) 582-1565
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place