Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy (HYPER)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University Hospital Birmingham.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Birmingham
Brighton and Sussex University Hospitals NHS Trust
British Heart Foundation
Information provided by:
University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT00989508
First received: October 2, 2009
Last updated: August 10, 2011
Last verified: April 2011

October 2, 2009
August 10, 2011
October 2009
September 2012   (final data collection date for primary outcome measure)
Absolute difference in Cardiac Index (>0.3 l/min/m2) [ Time Frame: 6 hours post-removal of aortic X-clamp ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00989508 on ClinicalTrials.gov Archive Site
  • Incidence of Low Cardiac Output Syndrome [ Time Frame: 6 hours post-removal of aortic X-clamp ] [ Designated as safety issue: No ]
  • Incidence of inotrope 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: 12 and 24 hours post-release of aortic X-clamp ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy
Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

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. Patients with a thickened wall of the heart (left ventricular hypertrophy) may be at greater risk. 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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Reperfusion Injury
  • Cardiac Output, Low
  • Hypertrophy, Left Ventricular
  • Drug: Perhexiline
    Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
    Other Name: PEXSIG
  • Drug: Placebo marked PEXSIG
    Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
  • Experimental: Perhexiline
    Pre-operative administration of Perhexiline tablets according to dosing schedule
    Intervention: Drug: Perhexiline
  • Placebo Comparator: Placebo marked PEXSIG
    Pre-operative administration of placebo tablets according to dosing schedule
    Intervention: Drug: Placebo marked PEXSIG

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
December 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult
  • First-time
  • Aortic valve surgery for aortic stenosis +/- coronary artery bypass

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
Both
18 Years and older
No
Contact: Eshan Senanayake, MBBS MRCS +44-7810-251454 eshan.senanayake@uhb.nhs.uk
Contact: Nigel E Drury, BM MRCS +44-7714-332364 nigel.drury@uhb.nhs.uk
United Kingdom
 
NCT00989508
RRK3535, Eudract 2008-002376-95, REC 08/H0304/48, BHF PG/08/040
Yes
Mr Domenico Pagano, University Hospital Birmingham
University Hospital Birmingham
  • University of Birmingham
  • Brighton and Sussex University Hospitals NHS Trust
  • British Heart Foundation
Principal Investigator: Domeinco Pagano, MD FRCS University Hospital Birmingham
University Hospital Birmingham
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP