Trial Outcomes & Findings for Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C (NCT NCT01381172)
NCT ID: NCT01381172
Last Updated: 2021-09-17
Results Overview
Exercise tolerance quantified by peak VO2 measured with cardiopulmonary exercise stress testing (CPX) and evaluated by a blinded core lab.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
24 weeks
Results posted on
2021-09-17
Participant Flow
Participant milestones
| Measure |
Treatment
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Control
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
No intervention: Optimal medical therapy: The control group receives optimal medical therapy only.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
86
|
|
Overall Study
COMPLETED
|
64
|
73
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C
Baseline characteristics by cohort
| Measure |
Treatment
n=74 Participants
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Control
n=86 Participants
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
No intervention: Optimal medical therapy: The control group receives optimal medical therapy only.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
n=5 Participants
|
60.0 years
n=7 Participants
|
60.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Peak VO2 (ml/kg/min)
|
15.36 ml/kg/min
STANDARD_DEVIATION 2.81 • n=5 Participants
|
15.49 ml/kg/min
STANDARD_DEVIATION 2.61 • n=7 Participants
|
15.425 ml/kg/min
STANDARD_DEVIATION 0.141 • n=5 Participants
|
|
Minnesota Living with Heart Failure Questionnaire (MLWHFQ) score
|
57.35 Score on a scale
STANDARD_DEVIATION 23.36 • n=5 Participants
|
56.42 Score on a scale
STANDARD_DEVIATION 22.95 • n=7 Participants
|
56.885 Score on a scale
STANDARD_DEVIATION 0.28991 • n=5 Participants
|
|
NYHA Class III
|
64 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
NYHA Class IV
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
6 Minute Hall Walk (meters)
|
324.07 meters
STANDARD_DEVIATION 89.71 • n=5 Participants
|
316.85 meters
STANDARD_DEVIATION 88.37 • n=7 Participants
|
320.46 meters
STANDARD_DEVIATION 0.94045 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksExercise tolerance quantified by peak VO2 measured with cardiopulmonary exercise stress testing (CPX) and evaluated by a blinded core lab.
Outcome measures
| Measure |
Treatment
n=74 Participants
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Control
n=86 Participants
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
No intervention: Optimal medical therapy: The control group receives optimal medical therapy only.
|
|---|---|---|
|
Peak VO2
|
15.28 ml/kg/min
Standard Deviation 3.66
|
14.79 ml/kg/min
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Randomized subjects
Change in quality of life at 24 weeks compared to baseline, as assessed by the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The MLWHFQ score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of lif
Outcome measures
| Measure |
Treatment
n=74 Participants
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Control
n=86 Participants
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
No intervention: Optimal medical therapy: The control group receives optimal medical therapy only.
|
|---|---|---|
|
Minnesota Living With Heart Failure (MLWHF) Questionnaire
|
35.26 score on a scale
Standard Deviation 24.63
|
47.47 score on a scale
Standard Deviation 25.65
|
SECONDARY outcome
Timeframe: 24 weeksPeak VO2 with change in respiratory exchange ratio (RER) included as a covariate, as measured by a blinded core lab.
Outcome measures
| Measure |
Treatment
n=74 Participants
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Control
n=86 Participants
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
No intervention: Optimal medical therapy: The control group receives optimal medical therapy only.
|
|---|---|---|
|
Peak VO2 With Respiratory Exchange Ratio (RER)
|
15.55 ml/kg/min
Standard Deviation 3.51
|
15.25 ml/kg/min
Standard Deviation 3.21
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Improvement of 1 NYHA class or more.
Heart failure class, as assessed by the New York Heart Association (NYHA) classification.
Outcome measures
| Measure |
Treatment
n=74 Participants
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Control
n=86 Participants
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
No intervention: Optimal medical therapy: The control group receives optimal medical therapy only.
|
|---|---|---|
|
NYHA
|
57 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPeak VO2 in an analysis that only includes tests with a peak RER of ≥1.05.
Outcome measures
| Measure |
Treatment
n=74 Participants
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Control
n=86 Participants
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
No intervention: Optimal medical therapy: The control group receives optimal medical therapy only.
|
|---|---|---|
|
Peak VO2 With a Peak RER of ≥1.05
|
1.13 ml/kg/min
Standard Deviation 0.96
|
1.1 ml/kg/min
Standard Deviation 0.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksDistance walked in 6 minutes
Outcome measures
| Measure |
Treatment
n=74 Participants
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Control
n=86 Participants
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
No intervention: Optimal medical therapy: The control group receives optimal medical therapy only.
|
|---|---|---|
|
6 Minute Hall Walk
|
324 meters
Standard Deviation 90
|
317 meters
Standard Deviation 88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksVE/VCO2 measured during cardiopulmonary stress testing (CPX) and evaluated by a blinded core lab.
Outcome measures
| Measure |
Treatment
n=74 Participants
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Control
n=86 Participants
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
No intervention: Optimal medical therapy: The control group receives optimal medical therapy only.
|
|---|---|---|
|
VE/VCO2
|
15.0 unitless
Standard Deviation 9.0
|
14.7 unitless
Standard Deviation 6.0
|
Adverse Events
Treatment
Serious events: 20 serious events
Other events: 35 other events
Deaths: 1 deaths
Control
Serious events: 19 serious events
Other events: 36 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment
n=74 participants at risk
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Control
n=86 participants at risk
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
No intervention: Optimal medical therapy: The control group receives optimal medical therapy only.
|
|---|---|---|
|
Cardiac disorders
Worsening Heart Failure
|
4.1%
3/74 • Number of events 4 • 24 Weeks Study Period
|
8.1%
7/86 • Number of events 8 • 24 Weeks Study Period
|
|
Cardiac disorders
Arrhythmia
|
4.1%
3/74 • Number of events 3 • 24 Weeks Study Period
|
2.3%
2/86 • Number of events 2 • 24 Weeks Study Period
|
|
Cardiac disorders
General Cardiopulmonary
|
4.1%
3/74 • Number of events 4 • 24 Weeks Study Period
|
2.3%
2/86 • Number of events 2 • 24 Weeks Study Period
|
|
General disorders
Bleeding
|
0.00%
0/74 • 24 Weeks Study Period
|
1.2%
1/86 • Number of events 1 • 24 Weeks Study Period
|
|
Cardiac disorders
Thromboembolism
|
1.4%
1/74 • Number of events 1 • 24 Weeks Study Period
|
1.2%
1/86 • Number of events 1 • 24 Weeks Study Period
|
|
Infections and infestations
Local Infection
|
1.4%
1/74 • Number of events 1 • 24 Weeks Study Period
|
4.7%
4/86 • Number of events 4 • 24 Weeks Study Period
|
|
Infections and infestations
Sepsis
|
1.4%
1/74 • Number of events 1 • 24 Weeks Study Period
|
1.2%
1/86 • Number of events 1 • 24 Weeks Study Period
|
|
Surgical and medical procedures
ICD or Pacemaker System Related
|
2.7%
2/74 • Number of events 2 • 24 Weeks Study Period
|
0.00%
0/86 • 24 Weeks Study Period
|
|
Surgical and medical procedures
OPTIMIZER System Related
|
8.1%
6/74 • Number of events 6 • 24 Weeks Study Period
|
0.00%
0/86 • 24 Weeks Study Period
|
|
General disorders
General Medical
|
24.3%
18/74 • Number of events 28 • 24 Weeks Study Period
|
19.8%
17/86 • Number of events 29 • 24 Weeks Study Period
|
Other adverse events
| Measure |
Treatment
n=74 participants at risk
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Optimizer System: The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Control
n=86 participants at risk
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
No intervention: Optimal medical therapy: The control group receives optimal medical therapy only.
|
|---|---|---|
|
Cardiac disorders
Arrhythmias
|
5.4%
4/74 • Number of events 4 • 24 Weeks Study Period
|
5.8%
5/86 • Number of events 5 • 24 Weeks Study Period
|
|
General disorders
Bleeding
|
2.7%
2/74 • Number of events 2 • 24 Weeks Study Period
|
1.2%
1/86 • Number of events 1 • 24 Weeks Study Period
|
|
Cardiac disorders
General Cardiopulmonary Event
|
9.5%
7/74 • Number of events 9 • 24 Weeks Study Period
|
7.0%
6/86 • Number of events 6 • 24 Weeks Study Period
|
|
General disorders
General Medical
|
24.3%
18/74 • Number of events 28 • 24 Weeks Study Period
|
19.8%
17/86 • Number of events 29 • 24 Weeks Study Period
|
|
Surgical and medical procedures
ICD or Pacemaker System Related
|
2.7%
2/74 • Number of events 2 • 24 Weeks Study Period
|
0.00%
0/86 • 24 Weeks Study Period
|
|
Infections and infestations
Localized Infection
|
6.8%
5/74 • Number of events 5 • 24 Weeks Study Period
|
3.5%
3/86 • Number of events 3 • 24 Weeks Study Period
|
|
Surgical and medical procedures
OPTIMIZER System Related
|
10.8%
8/74 • Number of events 9 • 24 Weeks Study Period
|
0.00%
0/86 • 24 Weeks Study Period
|
|
Cardiac disorders
Worsening Heart Failure
|
12.2%
9/74 • Number of events 11 • 24 Weeks Study Period
|
11.6%
10/86 • Number of events 12 • 24 Weeks Study Period
|
Additional Information
Sr. Director, Clinical and Data Operations
Impulse Dynamics (USA) Inc
Phone: 8453592389
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place