Myocardial Reperfusion InjuryPhase 2/3HYPERNCT00989508
Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy
A Phase 2/3 study testing Perhexiline in people with Myocardial Reperfusion Injury and Cardiac Output, Low, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Reperfusion Injury, Cardiac Output, Low, Hypertrophy, Left Ventricular
- What is being tested?
- Perhexiline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- First-time
- Aortic valve surgery for aortic stenosis +/- coronary artery bypass
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Birmingham
Birmingham, West Midlands, B15 2TH
Eshan Senanayake, MBBS MRCS, +44-7810-251454, eshan.senanayake@uhb.nhs.uk
Nigel E Drury, BM MRCS, +44-7714-332364, nigel.drury@uhb.nhs.uk
About this study
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.
- Being tested
- Perhexiline, Placebo marked PEXSIG
- Keywords
- Perhexiline, Aortic Valve Stenosis, Hypertrophy, Left Ventricular, Myocardial Reperfusion Injury, Cardiac Output, Low, Troponin
- Medical subject headings
- Myocardial Reperfusion Injury, Cardiac Output, Low, Hypertrophy, Left Ventricular, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerhexilineDrug
Also called PEXSIG
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
Placebo marked PEXSIGDrug
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
| Study group | Role | What they receive |
|---|---|---|
| Perhexiline | Experimental | Pre-operative administration of Perhexiline tablets according to dosing schedule Receives: Drug: Perhexiline |
| Placebo marked PEXSIG | Placebo comparator | Pre-operative administration of placebo tablets according to dosing schedule Receives: Drug: Placebo marked PEXSIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute difference in Cardiac Index (>0.3 l/min/m2)
Measured: 6 hours post-removal of aortic X-clamp
Secondary outcomes (3)
Incidence of Low Cardiac Output Syndrome
Measured: 6 hours post-removal of aortic X-clamp
Incidence of inotrope use according to protocol
Measured: 6 and 12 hours post-removal of aortic X-clamp
Peak and total release of Troponin
Measured: 12 and 24 hours post-release of aortic X-clamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial Reperfusion InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, Brighton and Sussex University Hospitals NHS Trust, British Heart Foundation
- Investigators
- Domeinco Pagano, MD FRCS, Principal investigator, University Hospital Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989508
- Sponsor's protocol ID
- RRK3535
- Other IDs
- Eudract 2008-002376-95, REC 08/H0304/48, BHF PG/08/040
- Acronym
- HYPER
- Status last verified
- Apr 2011
- First submitted
- 2 Oct 2009
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
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 16399292Ranasinghe 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 16820580Ashrafian 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy
- ClinicalTrials.gov ID
- NCT00989508
- Acronym / sponsor ID
- HYPER / RRK3535
- Keywords
- Perhexiline, Aortic Valve Stenosis, Hypertrophy, Left Ventricular, Myocardial Reperfusion Injury, Cardiac Output, Low, Troponin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Collaborators
- University of Birmingham, Brighton and Sussex University Hospitals NHS Trust, British Heart Foundation
- Study start
- Oct 2009
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 5 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perhexiline | Experimental | Drug: PerhexilinePre-operative administration of Perhexiline tablets according to dosing schedule |
| Placebo marked PEXSIG | Placebo comparator | Drug: Placebo marked PEXSIGPre-operative administration of placebo tablets according to dosing schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult
- First-time
- Aortic valve surgery for aortic stenosis +/- coronary artery bypass
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerhexilineAlso: PEXSIGTablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days. | Drug | Perhexiline |
| Placebo marked PEXSIGTablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days. | Drug | Placebo marked PEXSIG |
Primary outcome
Absolute difference in Cardiac Index (>0.3 l/min/m2)
Time frame: 6 hours post-removal of aortic X-clamp
3 secondary outcomes
Incidence of Low Cardiac Output Syndrome
Time frame: 6 hours post-removal of aortic X-clamp
Incidence of inotrope use according to protocol
Time frame: 6 and 12 hours post-removal of aortic X-clamp
Peak and total release of Troponin
Time frame: 12 and 24 hours post-release of aortic X-clamp
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
- Background: PubMed 16399292Quinn 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.
- Background: PubMed 16820580Ranasinghe 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.
- Background: PubMed 17445089Ashrafian H, Horowitz JD, Frenneaux MP. Perhexiline. Cardiovasc Drug Rev. 2007 Spring;25(1):76-97. doi: 10.1111/j.1527-3466.2007.00006.x.
Related trials for Myocardial Reperfusion Injury
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
RecruitingObservational study
Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
Myocardial Ischemia, Heart Defects, Congenital
Active, not recruitingPhase 2
Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI
Reperfusion Injury, Myocardial, Myocardial Infarction
Not yet recruitingPhase 2
Combined Antioxidant Therapy for Acute Myocardial Infarction
Acute Myocardial Infarction (AMI), ST Elevation (STEMI) Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domeinco Pagano, MD FRCS principal investigator
University Hospital Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Perhexiline in people with Myocardial Reperfusion Injury and Cardiac Output, Low, run by University Hospital Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eshan Senanayake, MBBS MRCS (+44-7810-251454, eshan.senanayake@uhb.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute difference in Cardiac Index (>0.3 l/min/m2) (time frame: 6 hours post-removal of aortic X-clamp). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00989508, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.