Condition category
Circulatory System
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
27/05/2015
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

Mr Roger Beadle

ORCID ID

Contact details

Department of Cardiovascular Medicine
Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

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

We are 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. We 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.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=7196

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

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

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

Publication citations

Additional files

Editorial Notes