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Metabolic manipulation in chronic heart failure: study protocol for a randomised controlled trial

Beadle, RM, Williams, LK, Abozguia, K, Patel, K, Leon, FL, Yousef, Z, Wagenmakers, AJM and Frenneaux, MP (2011) Metabolic manipulation in chronic heart failure: study protocol for a randomised controlled trial. Trials, 12. ISSN 1745-6215

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Abstract

Background: Heart failure is a major cause of morbidity and mortality in society. Current medical therapy centres on neurohormonal modulation with angiotensin converting enzyme inhibitors and b-blockers. There is growing evidence for the use of metabolic manipulating agents as adjunctive therapy in patients with heart failure. We aim to determine the effect of perhexiline on cardiac energetics and alterations in substrate utilisation in patients with non-ischaemic dilated cardiomyopathy.
Methods: A multi-centre, prospective, randomised double-blind, placebo-controlled trial of 50 subjects with nonischaemic dilated cardiomyopathy recruited from University Hospital Birmingham NHS Foundation Trust and Cardiff and Vale NHS Trust. Baseline investigations include magnetic resonance spectroscopy to assess cardiac energetic status, echocardiography to assess left ventricular function and assessment of symptomatic status. Subjects are then randomised to receive 200 mg perhexiline maleate or placebo daily for 4 weeks with serum drug level monitoring. All baseline investigations will be repeated at the end of the treatment period. A subgroup of patients will undergo invasive investigations with right and left heart catheterisation to calculate respiratory quotient, and mechanical efficiency. The primary endpoint is an improvement in the phosphocreatine to adenosine triphosphate ratio at 4 weeks. Secondary end points are: i) respiratory quotient; ii) mechanical efficiency; iii) change in left ventricular (LV) function.

Item Type: Article
Uncontrolled Keywords: 1102 Cardiovascular Medicine And Haematology, 1103 Clinical Sciences
Subjects: R Medicine > R Medicine (General)
R Medicine > RM Therapeutics. Pharmacology
Divisions: Sport & Exercise Sciences
Publisher: BioMed Central
Related URLs:
Date Deposited: 23 Jan 2018 10:05
Last Modified: 04 Sep 2021 04:19
DOI or ID number: 10.1186/1745-6215-12-140
URI: https://researchonline.ljmu.ac.uk/id/eprint/3249
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