Condition category
Circulatory System
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
11/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roger Beadle

ORCID ID

Contact details

Edgbaston
Birmingham
B15 2TT
United Kingdom

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 measures

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

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

http://www.uhb.nhs.uk/

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

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21645332

Publication citations

  1. 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.

Additional files

Editorial Notes