Trial Outcomes & Findings for Cardiovascular and Neurohormonal Effects of Faster Atrial Pacing Rate (NCT NCT00698139)
NCT ID: NCT00698139
Last Updated: 2018-04-27
Results Overview
The difference between post and pre CO
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
baseline and 6 hours
Results posted on
2018-04-27
Participant Flow
Overall 3 subjects completed the study. One subject underwent the intervention only (i.e., 6 hours of faster pacing). Subsequently the protocol was modified to a prospective, randomized single-blind, cross over design. Two subjects completed the protocol according to this modification and underwent both real and sham intervention.
Participant milestones
| Measure |
Intervention First, Then Control
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter.
|
Control First, Then Intervention
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter.
|
Intervention Only
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
|
Overall Study
2nd Visit
|
1
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cardiovascular and Neurohormonal Effects of Faster Atrial Pacing Rate
Baseline characteristics by cohort
| Measure |
Intervention First, Then Control
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter.
|
Control First, Then Intervention
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter.
|
Intervention Only
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 0 • n=5 Participants
|
85 years
STANDARD_DEVIATION 0 • n=7 Participants
|
84 years
STANDARD_DEVIATION 0 • n=5 Participants
|
69 years
STANDARD_DEVIATION 27 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 hoursThe difference between post and pre CO
Outcome measures
| Measure |
Intervention First, Then Control
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter.
|
Control First, Then Intervention
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter.
|
Intervention Only
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
|
|---|---|---|---|
|
Change in Cardiac Output (CO)
1st Visit
|
-0.14 L/min
Standard Deviation 0
|
-0.05 L/min
Standard Deviation 0
|
1.36 L/min
Standard Deviation 0
|
|
Change in Cardiac Output (CO)
2nd Visit
|
0.95 L/min
Standard Deviation 0
|
2.15 L/min
Standard Deviation 0
|
NA L/min
Standard Deviation NA
Subject did not have a 2nd visit.
|
SECONDARY outcome
Timeframe: baseline and 6 hoursImpedence will be measured using the pacemaker programmer to determine the difference in thoracic impedence pre- and post-procedure.
Outcome measures
| Measure |
Intervention First, Then Control
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter.
|
Control First, Then Intervention
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter.
|
Intervention Only
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
|
|---|---|---|---|
|
Changes in Thoracic Impedence
1st Visit
|
3.8 ohm
Standard Deviation 0
|
0 ohm
Standard Deviation 0
|
1.2 ohm
Standard Deviation 0
|
|
Changes in Thoracic Impedence
2nd Visit
|
2.6 ohm
Standard Deviation 0
|
-1.4 ohm
Standard Deviation 0
|
NA ohm
Standard Deviation NA
Subject did not have a 2nd visit.
|
SECONDARY outcome
Timeframe: baseline and 6 hoursB-type natriuretic peptide (BNP) was measured for all subjects to determint the difference between pre- and post-procedure.
Outcome measures
| Measure |
Intervention First, Then Control
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter.
|
Control First, Then Intervention
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter.
|
Intervention Only
n=1 Participants
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.
Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.
|
|---|---|---|---|
|
Changes in B-type Natriuretic Peptide (BNP)
1st Visit
|
265 ng/L
Standard Deviation 0
|
19 ng/L
Standard Deviation 0
|
110 ng/L
Standard Deviation 0
|
|
Changes in B-type Natriuretic Peptide (BNP)
2nd Visit
|
261 ng/L
Standard Deviation 0
|
92 ng/L
Standard Deviation 0
|
NA ng/L
Standard Deviation NA
Subject did not have a 2nd visit.
|
Adverse Events
Intervention First, Then Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control First, Then Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Only
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