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Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery

NCT00845364 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2010-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Myocardial Reperfusion Injury
  • Cardiac Output, Low

Interventions

DRUG

Perhexiline

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

DRUG

Placebo marked PEXSIG

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

Sponsors & Collaborators

  • University of Birmingham

    collaborator OTHER

  • Brighton and Sussex University Hospitals NHS Trust

    collaborator OTHER

  • British Heart Foundation

    collaborator OTHER

  • University Hospital Birmingham

    lead OTHER

Principal Investigators

  • Domeinco Pagano, MD FRCS · University Hospital Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00845364 on ClinicalTrials.gov