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Clinical Trial Protocol

Randomized double-blind placebo-controlled Trial of Perhexiline in Heart Failure With Preserved Ejection Fraction Syndrome

, , , , , , , , , , & show all
Pages 693-698 | Published online: 12 Dec 2014
 

ABSTRACT 

Recently heart failure with preserved ejection fraction (HFpEF) has emerged as a huge epidemic. Increasing evidence shows the role of energy deficiency in the pathophysiology of HFpEF. In the current study, we hypothesize that the use of metabolic modulator perhexiline would correct myocardial energy deficiency and improve exercise capacity and diastolic abnormalities in patients with this syndrome.

Other information

Eudra CT number: 2006–001109–28

Trial registration: ClinicalTrials.gov: NCT00839228

Acknowledgements

We are very grateful to John Webster for referring us patients from his clinics. We would also like to thank Alun Hutchings for advising on dose and dummy dose titration.

Financial & competing interests disclosure

The authors thank the British Heart Foundation for funding this study through a grant. Frenneaux is inventor on method of use patents for perhexiline in heart muscle diseases. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical disclosure

The protocol has been approved by south Birmingham research ethics committee and has received clinical authorisation from the Medicines and Healthcare Products Regulatory Agency (MHRA).

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