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

NCT01330654 | Withdrawn DMC

• 1 other identifier: 2010030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Event Risk

Keywords

Intermediate risk of adverse cardiac event; Undergoing laparoscopic surgical procedure; Age forty to seventy five

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  2 weeks

Study Arms (2)

Beta blocker

ACTIVE COMPARATOR

These patients will be randomized to receive a standard dose of metoprolol (50mg) starting two weeks prior to surgery

Drug: metoprolol

Control

NO INTERVENTION

This arm will receive no additional treatment prior to surgery

Interventions

metoprolol DRUG

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.

Beta blocker

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93701, United States

Location

Related Publications (7)

• 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.

  PMID: 16754815 BACKGROUND

• 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.

  PMID: 8737210 BACKGROUND

• 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.

  PMID: 3812275 BACKGROUND

• 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.

  PMID: 10588963 BACKGROUND

• 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.

  PMID: 16700875 BACKGROUND

• 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.

  PMID: 17070177 BACKGROUND

• 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.

  PMID: 18479744 BACKGROUND

Related Links

• PhysioNet is a database of physiologic signals and contains information on heart rate variability

MeSH Terms

Interventions

Metoprolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Ralph Wessel, MD

  UCSF Fresno Department of Internal Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 7, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 27, 2012

Record last verified: 2012-06

Locations

US (1)