Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7196
Study information
Scientific title
Randomised double-blind controlled trial of Perhexiline in heart failure with preserved ejection fraction syndrome (HFpEF)
Acronym
Perhexiline in HFpEF
Study hypothesis
This study is investigating the effect of perhexiline on patients with heart failure and preserved ejection fraction (HFpEF). Heart failure is a condtion that is defined by the heart's impaired energetic status. the trialists hypothesise that by improving the heart's energetic staus with the metabolic modulating drug perhexiline, we will improve the patients exercise capacity. This improvement in exercise capacity will be due to improved cardiac energetics and improved diastolic function.
Ethics approval
MREC approved (ref: 08/H1207/84)
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention
Perhexiline/placebo randomised in a 50:50 fashion. The perhexiline is started at 100 mg per oral twice daily (bd) and titrated according to serum levels. The medication is ceased after 3 months of therapy.
Follow-up length: 3 months
Study entry: single randomisation only
Intervention type
Drug
Phase
Phase III
Drug names
Perhexiline
Primary outcome measures
Peak oxygen consumption (VO2 max)
Secondary outcome measures
Symptomatic status (Modified Minnesota Living with Heart Failure Questionnaire)
Overall trial start date
01/03/2009
Overall trial end date
30/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
Heart failure normal ejection fraction diagnosed by signs or symptoms of heart failure and limitation on metabolic exercise testing
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 50
Participant exclusion criteria
1. Renal or liver impairment
2. Atrial fibrillation
3. Contraindication to magnetic resonance imaging (MRI)
4. Contraindication to perhexiline
Recruitment start date
01/03/2009
Recruitment end date
30/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University Hospital Birmingham NHS Foundation Trust (UK)
Sponsor details
Department of Cardiothoracic Surgery
Edgbaston
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
Results - basic reporting
Publication summary