Metabolic Manipulation in chronic heart failure
| ISRCTN | ISRCTN72887836 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72887836 |
| ClinicalTrials.gov number | NCT00841139 |
| Secondary identifying numbers | 3741 |
- Submission date
- 19/05/2010
- Registration date
- 19/05/2010
- Last edited
- 01/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Roger Beadle
Scientific
Scientific
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) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Metabolic changes induced by perhexiline versus placebo on myocardial metabolism in chronic heart failure: a multicentre randomised interventional treatment trial |
| Study objectives | 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(s) | South Birmingham REC approved on the 12th May 2006 (ref: 06/Q2707/7) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 04/09/2006 |
| Completion date | 04/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 50 |
| Key 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% |
| Key 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 |
| Date of first enrolment | 04/09/2006 |
| Date of final enrolment | 04/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Edgbaston
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University Hospitals Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Office
PO Box 9551
Mindelsohn Way
Queen Elizabeth Medical Centre
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/06/2011 | Yes | No | |
| Results article | results | 01/03/2015 | Yes | No |
Editorial Notes
01/10/2018: Publication reference added.
