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WithdrawnNCT01330654Updated Jun 27, 2012

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

An interventional study of metoprolol in Cardiac Event Risk, sponsored by University of California, San Francisco. Withdrawn at 1 site in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-27.

Sponsored by University of California, San Francisco · Not applicable and Interventional

Why this study was withdrawn
no patients were enrolled. Study was closed prior to study start.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • Cardiac Event Risk

Keywords

  • Intermediate risk of adverse cardiac event
  • Undergoing laparoscopic surgical procedure
  • Age forty to seventy five
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

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Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
0 participants (actual)

Study arms

  • 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

  • No intervention
    Control

    This arm will receive no additional treatment prior to surgery

Interventions

  • Drugmetoprolol

    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.

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What researchers measure

Primary outcomes

  1. Heart Rate Variability

    Time frame: 2 weeks

07

Study locations

1 site
  • Community Regional Medical Center
    Fresno, California 93701, United States
08

References and documents

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. doi: 10.1161/CIRCULATIONAHA.106.176009. No abstract available. PubMed 16754815 ↗
  • Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available. PubMed 8737210 ↗
  • Kleiger RE, Miller JP, Bigger JT Jr, Moss AJ. Decreased heart rate variability and its association with increased mortality after acute myocardial infarction. Am J Cardiol. 1987 Feb 1;59(4):256-62. doi: 10.1016/0002-9149(87)90795-8. PubMed 3812275 ↗
  • Poldermans D, Boersma E, Bax JJ, Thomson IR, van de Ven LL, Blankensteijn JD, Baars HF, Yo TI, Trocino G, Vigna C, Roelandt JR, van Urk H. The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group. N Engl J Med. 1999 Dec 9;341(24):1789-94. doi: 10.1056/NEJM199912093412402. PubMed 10588963 ↗
  • Beckers F, Verheyden B, Ramaekers D, Swynghedauw B, Aubert AE. Effects of autonomic blockade on non-linear cardiovascular variability indices in rats. Clin Exp Pharmacol Physiol. 2006 May-Jun;33(5-6):431-9. doi: 10.1111/j.1440-1681.2006.04384.x. PubMed 16700875 ↗
  • Yang H, Raymer K, Butler R, Parlow J, Roberts R. The effects of perioperative beta-blockade: results of the Metoprolol after Vascular Surgery (MaVS) study, a randomized controlled trial. Am Heart J. 2006 Nov;152(5):983-90. doi: 10.1016/j.ahj.2006.07.024. PubMed 17070177 ↗
  • POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Malaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12. PubMed 18479744 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01330654
Lead sponsor
University of California, San Francisco
First posted
Apr 7, 2011
Start date
Mar 2011
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Jun 27, 2012

Study contacts

Ralph Wessel, MD
study director · UCSF Fresno Department of Internal Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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