Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery (CASPER)

This study has been completed.
Sponsor:
Collaborators:
University of Birmingham
Brighton and Sussex University Hospitals NHS Trust
British Heart Foundation
Information provided by:
University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT00845364
First received: February 17, 2009
Last updated: May 19, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Myocardial Reperfusion Injury
Cardiac Output, Low
Drug: Perhexiline
Drug: Placebo marked PEXSIG
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital Birmingham:

Primary Outcome Measures:
  • Incidence of Low Cardiac Output Syndrome [ Time Frame: 6 hours post-removal of aortic X-clamp ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of inotropes use according to protocol [ Time Frame: 6 and 12 hours post-removal of aortic X-clamp ] [ Designated as safety issue: No ]
  • Peak and total release of Troponin [ Time Frame: 6, 12 and 24 hours post-release of aortic X-clamp ] [ Designated as safety issue: No ]

Enrollment: 290
Study Start Date: February 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perhexiline
Pre-operative administration of Perhexiline tablets according to dosing schedule
Drug: Perhexiline
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
Other Name: PEXSIG
Placebo Comparator: Placebo
Pre-operative administration of placebo tablets according to dosing schedule
Drug: Placebo marked PEXSIG
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845364

Locations
United Kingdom
University Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH
Brighton & Sussex University Hospitals NHS Trust
Brighton, West Sussex, United Kingdom, BN2 5BE
Sponsors and Collaborators
University Hospital Birmingham
University of Birmingham
Brighton and Sussex University Hospitals NHS Trust
British Heart Foundation
Investigators
Principal Investigator: Domeinco Pagano, MD FRCS University Hospital Birmingham
  More Information

Publications:
Responsible Party: Mr Domenico Pagano, University Hospital Birmingham
ClinicalTrials.gov Identifier: NCT00845364     History of Changes
Other Study ID Numbers: RRK3217, Eudract 2006-003164-62, REC 06/Q0104/141, BHF PG/06/044/20703
Study First Received: February 17, 2009
Last Updated: May 19, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by University Hospital Birmingham:
Perhexiline
Coronary artery bypass
Myocardial reperfusion injury
Cardiac output, low
Troponin

Additional relevant MeSH terms:
Cardiac Output, Low
Myocardial Reperfusion Injury
Reperfusion Injury
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Cardiomyopathies
Myocardial Ischemia
Vascular Diseases
Postoperative Complications
Pathologic Processes
Perhexiline
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on August 27, 2014