Cardiovascular and Neurohormonal Effects of Faster Atrial Pacing Rate

• ClinicalTrials.gov Identifier: NCT00698139
• Recruitment Status: Terminated
• First Posted: June 17, 2008
• Results First Posted: July 14, 2014
• Last Update Posted: April 27, 2018
• Sponsor: Columbia University
• Collaborator: Medtronic
• Information provided by (Responsible Party): Paolo Colombo, Columbia University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Heart Failure
• Intervention: Device: Medtronic Pacemaker
• Enrollment: 3

Participant Flow

Recruitment Details	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.
Pre-assignment Details

Arm/Group Title	Intervention First, Then Control	Control First, Then Intervention	Intervention Only
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
Started	1	1	1
2nd Visit	1	1	0 [1]
Completed	1	1	1
Not Completed	0	0	0
[1] 1 subject in the Intervention Group did not have a 2nd visit (per design).

Baseline Characteristics

Arm/Group Title		Intervention First, Then Control	Control First, Then Intervention	Intervention Only	Total
Arm/Group Description		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.	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.	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 of all reporting groups
Overall Number of Baseline Participants		1	1	1	3
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	1 participants	1 participants	1 participants	3 participants
		48 (0)	85 (0)	84 (0)	69 (27)
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants	1 participants	1 participants	3 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	1 100.0%	0 0.0%	0 0.0%	1 33.3%
	>=65 years	0 0.0%	1 100.0%	1 100.0%	2 66.7%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants	1 participants	1 participants	3 participants
	Female	1 100.0%	1 100.0%	1 100.0%	3 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Change in Cardiac Output (CO)
Description	The difference between post and pre CO
Time Frame	baseline and 6 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention First, Then Control	Control First, Then Intervention	Intervention Only
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	1	1	1
Mean (Standard Deviation); Unit of Measure: L/min
1st Visit	-0.14 (0)	-0.05 (0)	1.36 (0)
2nd Visit	0.95 (0)	2.15 (0)	NA [1] (NA)

[1]

Subject did not have a 2nd visit.

2. Secondary Outcome

Title	Changes in Thoracic Impedence
Description	Impedence will be measured using the pacemaker programmer to determine the difference in thoracic impedence pre- and post-procedure.
Time Frame	baseline and 6 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention First, Then Control	Control First, Then Intervention	Intervention Only
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	1	1	1
Mean (Standard Deviation); Unit of Measure: ohm
1st Visit	3.8 (0)	0 (0)	1.2 (0)
2nd Visit	2.6 (0)	-1.4 (0)	NA [1] (NA)

[1]

Subject did not have a 2nd visit.

3. Secondary Outcome

Title	Changes in B-type Natriuretic Peptide (BNP)
Description	B-type natriuretic peptide (BNP) was measured for all subjects to determint the difference between pre- and post-procedure.
Time Frame	baseline and 6 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention First, Then Control	Control First, Then Intervention	Intervention Only
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	1	1	1
Mean (Standard Deviation); Unit of Measure: ng/L
1st Visit	265 (0)	19 (0)	110 (0)
2nd Visit	261 (0)	92 (0)	NA [1] (NA)

[1]

Subject did not have a 2nd visit.

Adverse Events

Time Frame	1 week
Adverse Event Reporting Description	telephone contact
Arm/Group Title	Intervention First, Then Control	Control First, Then Intervention	Intervention Only
Arm/Group Description	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.	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.	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.
All-Cause Mortality
	Intervention First, Then Control	Control First, Then Intervention	Intervention Only
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Intervention First, Then Control	Control First, Then Intervention	Intervention Only
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/1 (0.00%)	0/1 (0.00%)	0/1 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Intervention First, Then Control	Control First, Then Intervention	Intervention Only
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/1 (0.00%)	0/1 (0.00%)	0/1 (0.00%)

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Paolo C. Colombo
• Organization: Columbia University
• Phone: 212-305-2638
• EMail: pcc2001@columbia.edu

• Responsible Party: Paolo Colombo, Columbia University
• ClinicalTrials.gov Identifier: NCT00698139
• Other Study ID Numbers: AAAC6786
• First Submitted: June 11, 2008
• First Posted: June 17, 2008
• Results First Submitted: January 28, 2014
• Results First Posted: July 14, 2014
• Last Update Posted: April 27, 2018