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Heart Rate Variability (HRV) to Evaluate Surgical Risk on Patients on Beta Blockers

This study has been withdrawn prior to enrollment.
(no patients were enrolled. Study was closed prior to study start.)
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01330654
First received: April 5, 2011
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

Beta blockers have been shown to decrease the risk of intraoperative cardiac events in patients at high cardiac risk. However, they have also been associated with side effects (for instance, stroke.) The role of beta blockers in patients at intermediate cardiac risk undergoing surgery is controversial. Heart rate variability is a way of evaluating the cardiac function of a patient. Decreased heart rate variability is associated with early cardiac death in patients with congestive heart failure (CHF) and after a heart attack. It has been shown to transiently decrease in patients in hemorrhagic shock after trauma and returns to normal after resuscitation in trauma and burn patients. The investigators hypothesize that beta blockers will maintain pre operative heart rate variability in patients with intermediate risk of cardiac events during operative intervention with laparoscopic surgery.


Condition Intervention
Cardiac Event Risk
 Drug: metoprolol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Using Heart Rate Variability to Analyze the Effect of Beta Blockers on Intermediate Risk Patients Undergoing Laparoscopic Surgical Procedures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Heart Rate Variability [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Beta blocker
These patients will be randomized to receive a standard dose of metoprolol (50mg) starting two weeks prior to surgery
 Drug: metoprolol
50mg PO BID starting two weeks prior to surgery. Patients will be reevaluated one week prior to surgery. If their pulse is above 70, the dose will be increased to 100mg BID. If the HR is 50-70, the dose will not be changed. If the pulse is below 50, the dose will be decreased to 25mg. This dose will be continued for thirty days after operation.
No Intervention: Control
This arm will receive no additional treatment prior to surgery

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 40-75 years old

  • intermediate risk of adverse cardiac events:

    • renal insufficiency (CrCl < 60)
    • diabetes mellitus

    • two of the following:

      • age > 50
      • obesity
      • hypertension
      • hyperlipidemia
      • hypercholesterolemia
      • prior stroke

    • undergoing an elective laparoscopic abdominal surgery less than three hours:

      • cholecystectomy
      • ventral hernia repair
      • umbilical hernia repair
      • gastric bypass or gastric banding

Exclusion Criteria:

  • currently taking a beta blocker
  • prior heart attack
  • rhythm other than sinus on ECG

  • contraindication to beta blockers:

    • decompensated CHF
    • severe valvular disease
    • asthma
    • COPD
    • hypersensitivity to beta blockers
    • heart rate < 60
  • currently taking a calcium channel blocker
  • urgent or emergent surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330654

Locations
United States, California
Community Regional Medical Center
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Director: Ralph Wessel, MD UCSF Fresno Department of Internal Medicine
  More Information

Additional Information:
PhysioNet is a database of physiologic signals and contains information on heart rate variability  This link exits the ClinicalTrials.gov site

Publications:
Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof E, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B; American College of Cardiology/American Heart Association Task Force on Practice Guidelines Writing Committee to Update the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Rhythm Society; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology. ACC/AHA 2006 guideline update on perioperative cardiovascular evaluation for noncardiac surgery: focused update on perioperative beta-blocker therapy: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society for Vascular Medicine and Biology. Circulation. 2006 Jun 6;113(22):2662-74. No abstract available.

Responsible Party: Jim Davis, Interim Program Director, Department of Surgery, UCSF Fresno
ClinicalTrials.gov Identifier: NCT01330654     History of Changes
Other Study ID Numbers: 2010030
Study First Received: April 5, 2011
Last Updated: June 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Intermediate risk of adverse cardiac event
Undergoing laparoscopic surgical procedure
Age forty to seventy five

Additional relevant MeSH terms:
Adrenergic beta-Antagonists
Metoprolol
Metoprolol succinate
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
 Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on June 17, 2013