Trial Outcomes & Findings for Effect of Chronic Changes in Heart Rate on Congestive Heart Failure (NCT NCT00389649)
NCT ID: NCT00389649
Last Updated: 2021-12-20
Results Overview
Ejection fraction as measured by nuclear ventriculography
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
2 months
Results posted on
2021-12-20
Participant Flow
Participant milestones
| Measure |
60, 75, 90
Pacemaker set at HR=60 for 1 month, 75 for 1 month and 90 for 1 month
|
60, 90, 75
HR=60 for 1 month, 90 for 1 month and 75 for 1 month
|
75, 60, 90
HR=75 for 1 month, 60 for 1 month and 90 for 1 month
|
75, 90, 60
HR=75 for 1 month, 90 for 1 month and 60 for 1 month
|
90, 60, 75
HR=90 for 1 month, 60 for 1 month and 75 for 1 month
|
90, 75, 60
HR=90 for 1 month, 75 for 1 month and 60 for 1 month
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
3
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Chronic Changes in Heart Rate on Congestive Heart Failure
Baseline characteristics by cohort
| Measure |
60,75,90
n=2 Participants
HR set at 60 for 1 month, then 75, then 90
|
60,90,75
n=2 Participants
HR set at 60 for 1 month, then 90, then 60
|
75, 60, 90
n=3 Participants
HR set at 75 for 1 month, then 60, then 90
|
75, 90, 60
n=2 Participants
HR set at 75 for 1 month, then 90, then 60
|
90, 60, 75
n=2 Participants
HR set at 90 for 1 month, then 60, then 75
|
90, 75,60
n=2 Participants
HR set at 90 for 1 month, then 75, then 60
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 2 monthsEjection fraction as measured by nuclear ventriculography
Outcome measures
| Measure |
HR=60
n=13 Participants
Pacemaker set at 60
heart rate setting
|
HR=75
n=13 Participants
Pacemaker set at 75
heart rate setting
|
HR=90
n=13 Participants
Pacemaker set at 90
heart rate setting
|
|---|---|---|---|
|
Ejection Fraction
|
33 % of blood ejected with each beat
Standard Deviation 6
|
30 % of blood ejected with each beat
Standard Deviation 6
|
25 % of blood ejected with each beat
Standard Deviation 6
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: 3 patients were unable to have peak oxygen consumption assessed at all 3 time points
Patients were exercised to exhaustion on a motorized treadmill using a modified Naughton protocol. Oxygen consumption, was calculated
Outcome measures
| Measure |
HR=60
n=10 Participants
Pacemaker set at 60
heart rate setting
|
HR=75
n=10 Participants
Pacemaker set at 75
heart rate setting
|
HR=90
n=10 Participants
Pacemaker set at 90
heart rate setting
|
|---|---|---|---|
|
Peak Oxygen Consumption
|
11.0 ml/kg/min
Standard Deviation 2.4
|
11.3 ml/kg/min
Standard Deviation 2.9
|
9.5 ml/kg/min
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 2 monthsPatients had submaximal exercise capacity evaluated by a 6-minute walk. This test was performed on a 100-foot hallway. Patients were instructed to walk from end to end repeatedly at a comfortable pace while attempting to cover as much ground as possible. After 6 minutes, the distance covered was measured to the nearest foot.
Outcome measures
| Measure |
HR=60
n=12 Participants
Pacemaker set at 60
heart rate setting
|
HR=75
n=12 Participants
Pacemaker set at 75
heart rate setting
|
HR=90
n=12 Participants
Pacemaker set at 90
heart rate setting
|
|---|---|---|---|
|
Distance Traveled During a 6 Minute Walk
|
938 feet
Standard Deviation 293
|
996 feet
Standard Deviation 260
|
888 feet
Standard Deviation 284
|
Adverse Events
HR=60
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HR=75
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HR=90
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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
- Publication restrictions are in place