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Status unknownNCT00989508HYPERUpdated Aug 11, 2011

Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

A Phase 2/3 interventional study of Perhexiline and Placebo marked PEXSIG in Myocardial Reperfusion Injury, Cardiac Output, Low and Hypertrophy, Left Ventricular, sponsored by University Hospital Birmingham. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-11.

Sponsored by University Hospital Birmingham · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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. 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.

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Conditions studied

  • Myocardial Reperfusion Injury
  • Cardiac Output, Low
  • Hypertrophy, Left Ventricular

Keywords

  • Perhexiline
  • Aortic Valve Stenosis
  • Hypertrophy, Left Ventricular
  • Myocardial Reperfusion Injury
  • Cardiac Output, Low
  • Troponin
03

In context

Reperfusion Injury

271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.

This study's planned enrollment of 220 is above the median of 61 across 215 interventional studies indexed under Reperfusion Injury.

Browse Reperfusion Injury studies →

Lead sponsor

University Hospital Birmingham is the lead sponsor of 32 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    Perhexiline

    Pre-operative administration of Perhexiline tablets according to dosing schedule

    Drug: Perhexiline

  • Placebo comparator
    Placebo marked PEXSIG

    Pre-operative administration of placebo tablets according to dosing schedule

    Drug: Placebo marked PEXSIG

Interventions

  • DrugPerhexiline

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

    Also known as: PEXSIG

  • DrugPlacebo marked PEXSIG

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

06

What researchers measure

Primary outcomes

  1. Absolute difference in Cardiac Index (>0.3 l/min/m2)

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

Secondary outcomes

  1. Incidence of Low Cardiac Output Syndrome

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

  2. Incidence of inotrope 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: 12 and 24 hours post-release of aortic X-clamp

07

Study locations

1 of 1 sites recruiting
  • University Hospital Birmingham
    Birmingham, West Midlands B15 2TH, United Kingdom
    • Eshan Senanayake, MBBS MRCS · Contact · eshan.senanayake@uhb.nhs.uk · +44-7810-251454
    • Nigel E Drury, BM MRCS · Contact · nigel.drury@uhb.nhs.uk · +44-7714-332364
    • Domenico Pagano, MD FRCS · Principal investigator
    • Timothy R Graham, FRCS · Sub investigator
    • Stephen J Rooney, FRCS · Sub investigator
    • Ian C Wilson, MD FRCS · Sub investigator
    • C Jorge G Mascaro, MD FRCS · Sub investigator
    Recruiting
08

References and documents

Publications

  • Quinn DW, Pagano D, Bonser RS, Rooney SJ, Graham TR, Wilson IC, Keogh BE, Townend JN, Lewis ME, Nightingale P; Study Investigators. Improved myocardial protection during coronary artery surgery with glucose-insulin-potassium: a randomized controlled trial. J Thorac Cardiovasc Surg. 2006 Jan;131(1):34-42. doi: 10.1016/j.jtcvs.2005.05.057. PubMed 16399292 ↗
  • Ranasinghe AM, Quinn DW, Pagano D, Edwards N, Faroqui M, Graham TR, Keogh BE, Mascaro J, Riddington DW, Rooney SJ, Townend JN, Wilson IC, Bonser RS. Glucose-insulin-potassium and tri-iodothyronine individually improve hemodynamic performance and are associated with reduced troponin I release after on-pump coronary artery bypass grafting. Circulation. 2006 Jul 4;114(1 Suppl):I245-50. doi: 10.1161/CIRCULATIONAHA.105.000786. PubMed 16820580 ↗
  • Ashrafian H, Horowitz JD, Frenneaux MP. Perhexiline. Cardiovasc Drug Rev. 2007 Spring;25(1):76-97. doi: 10.1111/j.1527-3466.2007.00006.x. PubMed 17445089 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00989508
Lead sponsor
University Hospital Birmingham
Collaborators
University of Birmingham, Brighton and Sussex University Hospitals NHS Trust, British Heart Foundation
First posted
Oct 5, 2009
Start date
Oct 2009
Primary completion
Sep 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Aug 11, 2011

Study contacts

Eshan Senanayake, MBBS MRCS
Contact
eshan.senanayake@uhb.nhs.uk
+44-7810-251454
Nigel E Drury, BM MRCS
Contact
nigel.drury@uhb.nhs.uk
+44-7714-332364
Domeinco Pagano, MD FRCS
principal investigator · University Hospital Birmingham

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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