Metabolic Manipulation in chronic heart failure
| ISRCTN | ISRCTN72887836 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72887836 |
| ClinicalTrials.gov (NCT) | NCT00841139 |
| Protocol serial number | 3741 |
| Sponsor | University Hospitals Birmingham NHS Foundation Trust (UK) |
| Funder | British Heart Foundation (BHF) (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Improvement in PCr/ATP ratio |
| Key secondary outcome measure(s) |
1. Change in mechanical efficiency (external work/ MVO2) |
| Completion date | 04/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Edgbaston
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | Yes | No | |
| Protocol article | protocol | 06/06/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/10/2018: Publication reference added.
