Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00841139
Protocol/serial number
3741
Study information
Scientific title
Metabolic changes induced by perhexiline versus placebo on myocardial metabolism in chronic heart failure: a multicentre randomised interventional treatment trial
Acronym
Study hypothesis
We wish to ivestigate the metabolic changes induced by perhexiline on myocardial metabolism in chronic heart failure. Perhexiline has been shown to improve exercise capacity in this group of patients. Perhexiline is thought to work by increasing carbohydrate metabolism and reducing fatty acid metabolism leading to improved metabolic efficiency. We plan to investigate myocardial metabolism both invasively and non-invasively to demonstate these changes.
Ethics approval
South Birmingham REC approved on the 12th May 2006 (ref: 06/Q2707/7)
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention
Perhexiline/Placebo 100 mg orally twice daily (bd) randomised in a 50:50 fashion with drug dose titration in accordance with serum levels.
Total duration of follow-up: one month
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Improvement in PCr/ATP ratio
Secondary outcome measures
1. Change in mechanical efficiency (external work/ MVO2)
2. Change in respiratory quotient
Overall trial start date
04/09/2006
Overall trial end date
04/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged greater than 18 years, no upper limit, either sex
2. Optimally medicated dilated cardiomyopathy
3. Symptomatic (New York Heart Association [NYHA] II - III)
4. Ejection fraction (EF) less than 40%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 50
Participant exclusion criteria
1. Implanted cardiac devices
2. Body mass index (BMI) greater than 32
3. Renal impairment
4. Liver function test abnormalities
5. Use of amiodarone
6. Selective serotonin reuptake inhibitor (SSRI) medications or haloperidol
Recruitment start date
04/09/2006
Recruitment end date
04/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University Hospitals Birmingham NHS Foundation Trust (UK)
Sponsor details
Research and Development Office
PO Box 9551
Mindelsohn Way
Queen Elizabeth Medical Centre
Birmingham
B15 2PR
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (BHF) (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21645332
2. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25650370
Publication citations
-
Protocol
Beadle RM, Williams LK, Abozguia K, Patel K, Leon FL, Yousef Z, Wagenmakers A, Frenneaux MP, Metabolic manipulation in chronic heart failure: study protocol for a randomised controlled trial., Trials, 2011, 12, 140, doi: 10.1186/1745-6215-12-140.