Status:
COMPLETED
Metabolic Manipulation in Chronic Heart Failure
Lead Sponsor:
University Hospital Birmingham NHS Foundation Trust
Collaborating Sponsors:
British Heart Foundation
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
16-90 years
Phase:
PHASE2
Brief Summary
Conventional measures used for the treatment of chronic heart failure act predominantly by reducing the work performed by the heart. In a recent study, the investigators showed that one drug (perhexil...
Detailed Description
Perhexiline maleate is an antianginal agent which increases the efficiency of energy production by shifting substrate utilisation from free fatty acids towards glucose. We showed that perhexiline ther...
Eligibility Criteria
Inclusion
- Optimally-medicated idiopathic dilated cardiomyopathy
- Symptomatic ( NYHA IIb-III)
- Impaired left ventricular systolic function (EF \< 40%)
Exclusion
- Abnormal liver function tests (defined as above twice the upper limit of normal (ULN))
- Concomitant use of Amiodarone , Quinidine , Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme.
- Pre-existing evidence of peripheral neuropathy.
- Women of childbearing potential.
- Patients with implantable cardiac devices (or any other contraindication to MRI).
- Obesity ( BMI \> 32)
- Obstructive sleep apnea syndrome
- Patients with known hypersensitivity to perhexiline
- Patients with impaired renal function (Creatinine \> 250 µmol/L)
- Valvular heart disease defined as more than moderate valvular stenosis or regurgitation.
- Atrial Fibrillation
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00841139
Start Date
February 1 2009
End Date
September 1 2011
Last Update
November 29 2011
Active Locations (2)
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1
University Hospitals Brimingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2TH
2
University of Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TT