Cardiovascular and Neurohormonal Effects of Faster Atrial Pacing Rate

NCT00698139 | Terminated Results

• 1 other identifier: AAAC6786
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; chronotropic incompetence

Outcome Measures

Primary Outcomes (1)

• Change in Cardiac Output (CO)

  The difference between post and pre CO

  baseline and 6 hours

Secondary Outcomes (2)

• Changes in Thoracic Impedence

  baseline and 6 hours

• Changes in B-type Natriuretic Peptide (BNP)

  baseline and 6 hours

Study Arms (3)

Intervention first, then control

ACTIVE COMPARATOR

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.

Device: Medtronic Pacemaker

Control first, then intervention

ACTIVE COMPARATOR

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.

Device: Medtronic Pacemaker

Intervention Only

ACTIVE COMPARATOR

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.

Device: Medtronic Pacemaker

Interventions

Medtronic Pacemaker DEVICE

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.

Also known as: Medtronic Cardiac Resynchronization Therapy (CRT), Dual Chamber Pacemaker

Control first, then intervention; Intervention Only; Intervention first, then control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18
• Congestive Heart Failure (CHF) (\>6 months duration)
• Left Ventricular Ejection Fraction (LVEF) \<40%
• Functional Class II-III
• Stable oral treatment (\>1 month),
• 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.
• Low heart rate (HR) (sinus rhythm (SR) or atrial pacing \<70 bpm)
• Symptomatically stable (with no clinical requirement for adjustments in medical therapy, i.e. diuretics)
• Increase in intrathoracic fluid as evidenced by rain natriuretic peptide (BNP) \>200.

You may not qualify if:

• Atrial fibrillation
• Stable or unstable angina
• Myocardial infarction within 6 months before the study
• Intravenous inotropic support
• Pregnant or breast feeding women. Women of child bearing potential must have a negative serum pregnancy test prior to enrollment.
• Severe renal failure (creatinine\> 2.5 mg/dl, hemodyalisis or peritoneal dialysis)
• Known hepatic impairment (total bilirubin \>3 mg/dL, albumin \<2.8 mg/dL, or increased ammonia levels if performed)
• Hemoglobin (hgb) \<8 mg %, or active bleeding requiring transfusion

Sponsors & Collaborators

• Columbia University: lead
• Medtronic: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Paolo C. Colombo
• Organization: Columbia University

pcc2001@columbia.edu

212-305-2638

Study Officials

• Paolo Colombo, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Herbert Irving Associate Professor of Medicine

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 17, 2008
• Study Start: April 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 27, 2018
• Results First Posted: July 14, 2014

Record last verified: 2014-07

Locations

US (1)