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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

Tracking Information
First Submitted Date  ICMJE June 11, 2008
First Posted Date  ICMJE June 17, 2008
Results First Submitted Date  ICMJE January 28, 2014
Results First Posted Date  ICMJE July 14, 2014
Last Update Posted Date April 27, 2018
Study Start Date  ICMJE April 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Change in Cardiac Output (CO) [ Time Frame: baseline and 6 hours ]
The difference between post and pre CO
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
Cardiac output [ Time Frame: 8 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2018)
  • Changes in Thoracic Impedence [ Time Frame: baseline and 6 hours ]
    Impedence will be measured using the pacemaker programmer to determine the difference in thoracic impedence pre- and post-procedure.
  • Changes in B-type Natriuretic Peptide (BNP) [ Time Frame: baseline and 6 hours ]
    B-type natriuretic peptide (BNP) was measured for all subjects to determint the difference between pre- and post-procedure.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
  • Changes in transthoracic impedence [ Time Frame: 8 hours ]
  • Changes in BNP [ Time Frame: 8 hours ]
  • Changes in Norepinephrine [ Time Frame: 8 hours ]
  • Changes in Renin [ Time Frame: 8 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiovascular and Neurohormonal Effects of Faster Atrial Pacing Rate
Official Title  ICMJE Cardiovascular and Neurohormonal Effects of Faster Atrial Pacing Rate for Six Hours in Patients With Congestive Heart Failure, Heart Rate <70 Beats Per Minute and Fluid Overload.
Brief Summary

Many patients with heart failure are unable to increase their heart rate appropriately when their body needs increased blood flow. As a result, they may be unable to mobilize excess fluid that their body retains. We hypothesize that we can provide assistance to their body in mobilizing this fluid by artificially increasing their heart rate using a pacemaker. We plan to conduct a prospective clinical trial to evaluate this hypothesis.

We will use a cross over design to study patients who already have biventricular pacemakers implanted or a narrow QRS and volume overload. We will screen them using a blood test that is a rough estimate of volume overload. Patients who meet the inclusion criteria will be randomly assigned to have their pacemakers adjusted or to have no intervention during the first of 2 visits. They will be unaware of which group they are in. Following adjustment, they will be monitored for six hours.

Prior to the pacemaker adjustment, several tests will be performed to evaluate heart function and the levels of hormones related that are affected by heart failure. These tests will be repeated at the end of the six hour intervention period in each visit. At the end of the visit patients who had their pacemakers adjusted will have it reset to their original settings.

Detailed Description

Many patients with heart failure suffer from chronotropic incompetence, an inability to raise their heart rate in response to metabolic demand. Previous studies have shown that brief increases in pacing rates in patients with biventricular pacemakers can improve cardiac contractility. We hypothesize that the benefits of an increased biventricular pacing rate could be sustained and would improve cardiovascular and neurohormonal parameters in patients suffering from volume overload. We intend to prospectively evaluate this hypothesis in a single blind randomized cross-over design trial.

We will screen 40 patients who have previously implanted biventricular pacemakers (or a narrow QRS) and an elevated B-type Natriuretic Peptide (BNP) level. Following enrollment, patients will be randomly assigned to have their atrial pacing rate increased to 85 beats per minute or to be unchanged during the first of 2 visits. Patients will be unaware of their treatment assignment. They will be observed for six hours in a monitored setting. The primary outcome will be cardiac output, as measured noninvasively by NICOM (Cheetah Medical Inc., Israel) system before and after the observation period. Secondary outcomes will include changes in neurohormonal measures and thoracic impedance. If this proof-of-concept study demonstrates a positive effect, future research would evaluate the ability of increased pacing rates to prevent or abort decompensation of Congestive Heart Failure (CHF).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: Medtronic Pacemaker
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 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.
Other Names:
  • Medtronic Cardiac Resynchronization Therapy (CRT)
  • Dual Chamber Pacemaker
Study Arms  ICMJE
  • Active Comparator: 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.

    Intervention: Device: Medtronic Pacemaker
  • Active Comparator: 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: Device: Medtronic Pacemaker
  • Active Comparator: 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.

    Intervention: Device: Medtronic Pacemaker
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 18, 2012)
3
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2008)
40
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age>18
  2. Congestive Heart Failure (CHF) (>6 months duration)
  3. Left Ventricular Ejection Fraction (LVEF) <40%
  4. Functional Class II-III
  5. Stable oral treatment (>1 month),
  6. Implanted Medtronic pacemaker/defibrillator with a) an atrial pacing lead and biventricular leads, or b) an atrial pacing lead and a single ventricular lead in patients with a narrow (normal) QRS complex (<120 msec) thus with no clinical indication for biventricular pacing.
  7. Low heart rate (HR) (sinus rhythm (SR) or atrial pacing <70 bpm)
  8. Symptomatically stable (with no clinical requirement for adjustments in medical therapy, i.e. diuretics)
  9. Increase in intrathoracic fluid as evidenced by rain natriuretic peptide (BNP) >200.

Exclusion criteria:

  1. Atrial fibrillation
  2. Stable or unstable angina
  3. Myocardial infarction within 6 months before the study
  4. Intravenous inotropic support
  5. Pregnant or breast feeding women. Women of child bearing potential must have a negative serum pregnancy test prior to enrollment.
  6. Severe renal failure (creatinine> 2.5 mg/dl, hemodyalisis or peritoneal dialysis)
  7. Known hepatic impairment (total bilirubin >3 mg/dL, albumin <2.8 mg/dL, or increased ammonia levels if performed)
  8. Hemoglobin (hgb) <8 mg %, or active bleeding requiring transfusion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00698139
Other Study ID Numbers  ICMJE AAAC6786
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paolo Colombo, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Principal Investigator: Paolo Colombo, MD Columbia University
PRS Account Columbia University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP