Trial Outcomes & Findings for Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5 (NCT NCT00112125)
NCT ID: NCT00112125
Last Updated: 2020-08-06
Results Overview
The proportion of patients experiencing a composite event of all-cause mortality and all-cause hospitalizations evaluated at 50-weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
428 participants
Primary outcome timeframe
50-weeks
Results posted on
2020-08-06
Participant Flow
Participant milestones
| Measure |
Control Group (OMT)
Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
|
Treatment (CCM + OMT)
Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
|
|---|---|---|
|
Overall Study
STARTED
|
213
|
215
|
|
Overall Study
COMPLETED
|
189
|
193
|
|
Overall Study
NOT COMPLETED
|
24
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5
Baseline characteristics by cohort
| Measure |
Control Group (OMT)
n=213 Participants
Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
|
Treatment (OMT + CCM)
n=215 Participants
Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
58.1 Years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
58.35 Years
STANDARD_DEVIATION 12.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
309 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 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
|
45 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
142 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
213 participants
n=5 Participants
|
215 participants
n=7 Participants
|
428 participants
n=5 Participants
|
|
Peak VO2
|
14.71 ml/kg/min
STANDARD_DEVIATION 2.92 • n=5 Participants
|
14.74 ml/kg/min
STANDARD_DEVIATION 3.06 • n=7 Participants
|
14.725 ml/kg/min
STANDARD_DEVIATION 2.99 • n=5 Participants
|
|
6 Minute Hall Walk Distance
|
324 meters
STANDARD_DEVIATION 92.4 • n=5 Participants
|
326.4 meters
STANDARD_DEVIATION 82.1 • n=7 Participants
|
325.2 meters
STANDARD_DEVIATION 7.28 • n=5 Participants
|
|
NYHA Class III
|
183 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
379 Participants
n=5 Participants
|
|
NYHA Class IV
|
29 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
MLWHFQ score
|
57.4 Score on a scale
STANDARD_DEVIATION 22.6 • n=5 Participants
|
60.5 Score on a scale
STANDARD_DEVIATION 23 • n=7 Participants
|
58.95 Score on a scale
STANDARD_DEVIATION 0.282 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Intention to treat (ITT) population
Number of participants with improvement in exercise tolerance at 24 weeks compared to baseline, as quantified by VO2 at ventilatory anerobic threshold (VAT) measured on cardiopulmonary exercise stress testing (CPX), and evaluated by a blinded core lab. Note: An individual subject is considered a responder if VAT increases by ≥20% at 24 weeks compared to their respective baseline value.
Outcome measures
| Measure |
Control Group (OMT)
n=213 Participants
Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
|
Treatment (CCM + OMT)
n=215 Participants
Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
|
|---|---|---|
|
Efficacy Endpoint: Ventilatory Anerobic Threshold (VAT)
|
28 Participants
|
38 Participants
|
PRIMARY outcome
Timeframe: 50-weeksPopulation: Intention-to-treat
The proportion of patients experiencing a composite event of all-cause mortality and all-cause hospitalizations evaluated at 50-weeks
Outcome measures
| Measure |
Control Group (OMT)
n=213 Participants
Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
|
Treatment (CCM + OMT)
n=215 Participants
Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
|
|---|---|---|
|
Safety Endpoint: Composite All-cause Mortality and All-cause Hospitalizations
|
103 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Completed cases
Number of participants with improvement in peak VO2 measured on cardiopulmonary exercise stress testing (CPX), and evaluated by a blinded core lab. Note: An individual subject is considered a responder if peak VO2 increases by ≥20% at 24 weeks compared to their respective baseline value.
Outcome measures
| Measure |
Control Group (OMT)
n=168 Participants
Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
|
Treatment (CCM + OMT)
n=179 Participants
Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
|
|---|---|---|
|
Peak VO2
|
23 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Completed cases
Number of participants with improvement in heart failure symptoms as quantified by a blinded clinician using the New York Heart Association (NYHA) functional classification at 24 weeks compared to baseline. The NYHA Class ranges from I - IV, with a lower class indicating a better status. Note: An individual subject is considered a responder if the NYHA class decreases by ≥ 1 at 24 weeks compared to their respective baseline class.
Outcome measures
| Measure |
Control Group (OMT)
n=183 Participants
Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
|
Treatment (CCM + OMT)
n=191 Participants
Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
|
|---|---|---|
|
New York Heart Association (NYHA) Functional Classification
|
63 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Completed cases
Number of subjects will improvement 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 life. Note: An individual subject is considered a responder if the MLWHFQ score decreases by ≥10 points at 24 weeks compared to their respective baseline score.
Outcome measures
| Measure |
Control Group (OMT)
n=184 Participants
Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
|
Treatment (CCM + OMT)
n=196 Participants
Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
|
|---|---|---|
|
Minnesota Living With Heart Failure (MLWHF) Questionnaire
|
77 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Completed cases
Number of subjects with improvement in exercise tolerance at 24 weeks compared to baseline, as assessed by the the six minute hall walk (6MW) test. Note: An individual subject is considered a responder with \>40-meter increase in distance walked at 24 weeks compared to their respective baseline distance.
Outcome measures
| Measure |
Control Group (OMT)
n=173 Participants
Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
|
Treatment (CCM + OMT)
n=190 Participants
Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
|
|---|---|---|
|
Six Minute Hall Walk (6MW) Test
|
51 Participants
|
65 Participants
|
Adverse Events
Control Group (OMT)
Serious events: 115 serious events
Other events: 135 other events
Deaths: 7 deaths
Treatment (CCM + OMT)
Serious events: 129 serious events
Other events: 152 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Control Group (OMT)
n=212 participants at risk
Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
|
Treatment (CCM + OMT)
n=210 participants at risk
Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
|
|---|---|---|
|
Cardiac disorders
General Cardiopulmonary Event
|
21.7%
46/212 • Number of events 58 • 50-weeks
|
20.0%
42/210 • Number of events 60 • 50-weeks
|
|
Cardiac disorders
Arrhythmia
|
11.8%
25/212 • Number of events 30 • 50-weeks
|
13.8%
29/210 • Number of events 40 • 50-weeks
|
|
General disorders
General Medical
|
25.5%
54/212 • Number of events 81 • 50-weeks
|
30.0%
63/210 • Number of events 98 • 50-weeks
|
|
Cardiac disorders
ICD or Pacemaker System Malfunction
|
2.8%
6/212 • Number of events 7 • 50-weeks
|
5.2%
11/210 • Number of events 13 • 50-weeks
|
|
Infections and infestations
Localized Infection
|
13.7%
29/212 • Number of events 36 • 50-weeks
|
12.9%
27/210 • Number of events 33 • 50-weeks
|
|
Cardiac disorders
Worsening Heart Failure
|
23.6%
50/212 • Number of events 85 • 50-weeks
|
23.8%
50/210 • Number of events 72 • 50-weeks
|
|
Blood and lymphatic system disorders
Bleeding
|
3.8%
8/212 • Number of events 8 • 50-weeks
|
2.9%
6/210 • Number of events 8 • 50-weeks
|
|
Infections and infestations
Sepsis
|
0.94%
2/212 • Number of events 2 • 50-weeks
|
4.8%
10/210 • Number of events 11 • 50-weeks
|
|
Nervous system disorders
Neurologic Dysfunction
|
5.7%
12/212 • Number of events 14 • 50-weeks
|
1.4%
3/210 • Number of events 3 • 50-weeks
|
|
Vascular disorders
Thromboembolism
|
2.4%
5/212 • Number of events 5 • 50-weeks
|
1.4%
3/210 • Number of events 3 • 50-weeks
|
|
Surgical and medical procedures
OPTIMIZER lead fracture
|
0.00%
0/212 • 50-weeks
|
1.4%
3/210 • Number of events 3 • 50-weeks
|
|
Surgical and medical procedures
OPTIMIZER RV lead dislodgement
|
0.00%
0/212 • 50-weeks
|
2.9%
6/210 • Number of events 6 • 50-weeks
|
|
Surgical and medical procedures
IPG problem/change
|
0.00%
0/212 • 50-weeks
|
0.48%
1/210 • Number of events 2 • 50-weeks
|
|
Surgical and medical procedures
OPTIMIZER RA lead dislodgement
|
0.00%
0/212 • 50-weeks
|
2.4%
5/210 • Number of events 6 • 50-weeks
|
|
Surgical and medical procedures
OPTIMIZER pocket dehiscence/erosion
|
0.00%
0/212 • 50-weeks
|
1.4%
3/210 • Number of events 3 • 50-weeks
|
|
Infections and infestations
OPTIMIZER pocket infection
|
0.00%
0/212 • 50-weeks
|
0.95%
2/210 • Number of events 2 • 50-weeks
|
|
Surgical and medical procedures
OPTIMIZER pocket stimulation
|
0.00%
0/212 • 50-weeks
|
0.95%
2/210 • Number of events 2 • 50-weeks
|
|
Surgical and medical procedures
Lead perforation
|
0.00%
0/212 • 50-weeks
|
0.95%
2/210 • Number of events 2 • 50-weeks
|
|
Blood and lymphatic system disorders
OPTIMIZER pocket bleeding
|
0.00%
0/212 • 50-weeks
|
0.48%
1/210 • Number of events 1 • 50-weeks
|
|
Surgical and medical procedures
Sensation due to CCM
|
0.00%
0/212 • 50-weeks
|
0.95%
2/210 • Number of events 2 • 50-weeks
|
|
Surgical and medical procedures
Extracardiac stimulation
|
0.00%
0/212 • 50-weeks
|
0.48%
1/210 • Number of events 1 • 50-weeks
|
Other adverse events
| Measure |
Control Group (OMT)
n=212 participants at risk
Optimal medical treatment (OMT). Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and B-blocker.
|
Treatment (CCM + OMT)
n=210 participants at risk
Treatment group: Subjects receiving OMT and cardiac contractility modulation therapy with the Optimizer System.
|
|---|---|---|
|
Cardiac disorders
General Cardiopulmonary Event
|
9.0%
19/212 • Number of events 21 • 50-weeks
|
19.5%
41/210 • Number of events 55 • 50-weeks
|
|
Cardiac disorders
Arrhythmias
|
6.1%
13/212 • Number of events 16 • 50-weeks
|
12.4%
26/210 • Number of events 29 • 50-weeks
|
|
Cardiac disorders
Worsening Heart Failure
|
13.7%
29/212 • Number of events 35 • 50-weeks
|
15.2%
32/210 • Number of events 35 • 50-weeks
|
|
Infections and infestations
Localized Infection
|
19.3%
41/212 • Number of events 50 • 50-weeks
|
24.3%
51/210 • Number of events 63 • 50-weeks
|
|
General disorders
General Medical
|
40.6%
86/212 • Number of events 167 • 50-weeks
|
50.0%
105/210 • Number of events 193 • 50-weeks
|
Additional Information
Angela Stagg, 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