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NCT Number: NCT00845364

Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery

Open-heart surgery causes injury of the heart muscle. Although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. During surgery, techniques are used to protect the heart from injury, but these remain imperfect. This study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug Perhexiline given before the operation. This treatment has a sound experimental basis for improving outcome. If this improvement is confirmed surgical results could be improved. The investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. The investigators' hypothesis is that Perhexiline will improve the protection of the heart by decreasing damage that may occur during heart surgery.

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Key information

Conditions

Myocardial Reperfusion Injury Cardiac Output, Low Cardiomyopathies Cardiovascular Diseases Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital Birmingham, Birmingham, West Midlands, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult
  • First-time
  • Isolated coronary artery bypass surgery

Exclusion criteria

  • Diabetes Mellitus
  • Renal impairment with Creatinine greater than or equal to 200micromol/L
  • Atrial fibrillation
  • Amiodarone therapy, recent (in last month) or current
  • Hepatic impairment, significant preoperative
  • Peripheral neuropathy
  • Pregnancy or breast-feeding
  • Emergency surgery or required on clinical grounds within 5 days of referral

Treatment and study plan

Perhexiline

Drug

Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.

Other names: PEXSIG

Placebo marked PEXSIG

Drug

Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.

Primary outcomes

  1. Incidence of Low Cardiac Output Syndrome

    Time frame: 6 hours post-removal of aortic X-clamp

Secondary outcomes

  1. Increase in Cardiac index of greater than or equal to 0.3 L/min/m2

    Time frame: 6 hours post-removal of aortic X-clamp

  2. Incidence of inotropes use according to protocol

    Time frame: 6 and 12 hours post-removal of aortic X-clamp

  3. Peak and total release of Troponin

    Time frame: 6, 12 and 24 hours post-release of aortic X-clamp

Sponsors and collaborators

Lead sponsor

University Hospital Birmingham

Other

Collaborators

  • Brighton and Sussex University Hospitals NHS Trust
  • British Heart Foundation
  • University of Birmingham

Registry information

Acronym: CASPER

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 18, 2009
Registry last updated
May 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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