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Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy (HYPER)

Primary Purpose

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

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Perhexiline
Placebo marked PEXSIG
Sponsored by
University Hospital Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Reperfusion Injury focused on measuring Perhexiline, Aortic Valve Stenosis, Hypertrophy, Left Ventricular, Myocardial Reperfusion Injury, Cardiac Output, Low, Troponin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Perhexiline

Placebo marked PEXSIG

Arm Description

Pre-operative administration of Perhexiline tablets according to dosing schedule

Pre-operative administration of placebo tablets according to dosing schedule

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Low Cardiac Output Syndrome
Incidence of inotrope use according to protocol
Peak and total release of Troponin

Full Information

First Posted
October 2, 2009
Last Updated
August 10, 2011
Sponsor
University Hospital Birmingham
Collaborators
University of Birmingham, Brighton and Sussex University Hospitals NHS Trust, British Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00989508
Brief Title
Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy
Acronym
HYPER
Official Title
Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Birmingham
Collaborators
University of Birmingham, Brighton and Sussex University Hospitals NHS Trust, British Heart Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Reperfusion Injury, Cardiac Output, Low, Hypertrophy, Left Ventricular
Keywords
Perhexiline, Aortic Valve Stenosis, Hypertrophy, Left Ventricular, Myocardial Reperfusion Injury, Cardiac Output, Low, Troponin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perhexiline
Arm Type
Experimental
Arm Description
Pre-operative administration of Perhexiline tablets according to dosing schedule
Arm Title
Placebo marked PEXSIG
Arm Type
Placebo Comparator
Arm Description
Pre-operative administration of placebo tablets according to dosing schedule
Intervention Type
Drug
Intervention Name(s)
Perhexiline
Other Intervention Name(s)
PEXSIG
Intervention Description
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
Intervention Type
Drug
Intervention Name(s)
Placebo marked PEXSIG
Intervention Description
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
Primary Outcome Measure Information:
Title
Absolute difference in Cardiac Index (>0.3 l/min/m2)
Time Frame
6 hours post-removal of aortic X-clamp
Secondary Outcome Measure Information:
Title
Incidence of Low Cardiac Output Syndrome
Time Frame
6 hours post-removal of aortic X-clamp
Title
Incidence of inotrope use according to protocol
Time Frame
6 and 12 hours post-removal of aortic X-clamp
Title
Peak and total release of Troponin
Time Frame
12 and 24 hours post-release of aortic X-clamp

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eshan Senanayake, MBBS MRCS
Phone
+44-7810-251454
Email
eshan.senanayake@uhb.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Nigel E Drury, BM MRCS
Phone
+44-7714-332364
Email
nigel.drury@uhb.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domeinco Pagano, MD FRCS
Organizational Affiliation
University Hospital Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Birmingham
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eshan Senanayake, MBBS MRCS
Phone
+44-7810-251454
Email
eshan.senanayake@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Nigel E Drury, BM MRCS
Phone
+44-7714-332364
Email
nigel.drury@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Domenico Pagano, MD FRCS
First Name & Middle Initial & Last Name & Degree
Timothy R Graham, FRCS
First Name & Middle Initial & Last Name & Degree
Stephen J Rooney, FRCS
First Name & Middle Initial & Last Name & Degree
Ian C Wilson, MD FRCS
First Name & Middle Initial & Last Name & Degree
C Jorge G Mascaro, MD FRCS

12. IPD Sharing Statement

Citations:
PubMed Identifier
16399292
Citation
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.
Results Reference
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PubMed Identifier
16820580
Citation
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.
Results Reference
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PubMed Identifier
17445089
Citation
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.
Results Reference
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Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

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