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Cardiovascular and Neurohormonal Effects of Faster Atrial Pacing Rate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00698139
Recruitment Status : Terminated (Closed by Sponsor)
First Posted : June 17, 2008
Results First Posted : July 14, 2014
Last Update Posted : April 27, 2018
Sponsor:
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
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
Hide 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).
Arm/Group Title Intervention First, Then Control Control First, Then Intervention Intervention Only Total
Hide 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
Hide 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%
1.Primary Outcome
Title Change in Cardiac Output (CO)
Hide Description The difference between post and pre CO
Time Frame baseline and 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention First, Then Control Control First, Then Intervention Intervention Only
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention First, Then Control Control First, Then Intervention Intervention Only
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention First, Then Control Control First, Then Intervention Intervention Only
Hide 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.
Time Frame 1 week
Adverse Event Reporting Description telephone contact
 
Arm/Group Title Intervention First, Then Control Control First, Then Intervention Intervention Only
Hide 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   --/--   --/--   --/-- 
Hide 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%) 
Hide 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%) 
Early termination leading to small numbers of subjects analyzed
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Paolo C. Colombo
Organization: Columbia University
Phone: 212-305-2638
EMail: pcc2001@columbia.edu
Layout table for additonal information
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