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
  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. 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.


Condition Intervention Phase
Myocardial Reperfusion Injury
Cardiac Output, Low
Hypertrophy, Left Ventricular
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: Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

Resource links provided by NLM:


Further study details as provided by University Hospital Birmingham:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 220
Study Start Date: October 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (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 marked PEXSIG
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
  • 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
  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: NCT00989508

Contacts
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

Locations
United Kingdom
University Hospital Birmingham Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
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   
Principal Investigator: Domenico Pagano, MD FRCS         
Sub-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         
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: NCT00989508     History of Changes
Other Study ID Numbers: RRK3535, Eudract 2008-002376-95, REC 08/H0304/48, BHF PG/08/040
Study First Received: October 2, 2009
Last Updated: August 10, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospital Birmingham:
Perhexiline
Aortic Valve Stenosis
Hypertrophy, Left Ventricular
Myocardial Reperfusion Injury
Cardiac Output, Low
Troponin

Additional relevant MeSH terms:
Cardiac Output, Low
Hypertrophy
Myocardial Reperfusion Injury
Reperfusion Injury
Hypertrophy, Left Ventricular
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Pathological Conditions, Anatomical
Cardiomyopathies
Myocardial Ischemia
Vascular Diseases
Postoperative Complications
Pathologic Processes
Cardiomegaly
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 September 14, 2014