Randomised double-blind controlled trial of Perhexiline in heart failure with preserved ejection fraction syndrome (HFpEF)
| ISRCTN | ISRCTN25678870 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25678870 |
| Secondary identifying numbers | 7196 |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 02/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Roger Beadle
Scientific
Scientific
Department of Cardiovascular Medicine
Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Multicentre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised double-blind controlled trial of Perhexiline in heart failure with preserved ejection fraction syndrome (HFpEF) |
| Study acronym | Perhexiline in HFpEF |
| Study objectives | 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(s) | MREC approved (ref: 08/H1207/84) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Perhexiline |
| Primary outcome measure | Peak oxygen consumption (VO2 max) |
| Secondary outcome measures | Symptomatic status (Modified Minnesota Living with Heart Failure Questionnaire) |
| Overall study start date | 01/03/2009 |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned sample size: 50 |
| Key inclusion criteria | Heart failure normal ejection fraction diagnosed by signs or symptoms of heart failure and limitation on metabolic exercise testing |
| Key exclusion criteria | 1. Renal or liver impairment 2. Atrial fibrillation 3. Contraindication to magnetic resonance imaging (MRI) 4. Contraindication to perhexiline |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University Hospital Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Department of Cardiothoracic Surgery
Edgbaston
Birmingham
B15 2PR
England
United Kingdom
| Website | http://www.uhb.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/014ja3n03 |
Funders
Funder type
Charity
British Heart Foundation (BHF) (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
02/10/2017: No publications found, verifying study status with principal investigator.
