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Metabolic manipulation in chronic heart failure: study protocol for a randomised controlled trial.
- Source :
-
Trials [Trials] 2011 Jun 06; Vol. 12, pp. 140. Date of Electronic Publication: 2011 Jun 06. - Publication Year :
- 2011
-
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 β-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.<br />Methods: A multi-centre, prospective, randomised double-blind, placebo-controlled trial of 50 subjects with non-ischaemic 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.<br />Trial Registration: ClinicalTrials.gov: NCT00841139 ISRCTN: ISRCTN72887836.
- Subjects :
- Adenosine Triphosphate metabolism
Cardiac Catheterization
Cardiomyopathy, Dilated complications
Cardiomyopathy, Dilated diagnosis
Cardiomyopathy, Dilated metabolism
Cardiomyopathy, Dilated physiopathology
Cardiovascular Agents blood
Double-Blind Method
Drug Monitoring
Echocardiography, Doppler
Heart Failure diagnosis
Heart Failure etiology
Heart Failure metabolism
Heart Failure physiopathology
Humans
Magnetic Resonance Imaging
Magnetic Resonance Spectroscopy
Perhexiline blood
Phosphocreatine metabolism
Placebo Effect
Prospective Studies
Recovery of Function
Stroke Volume drug effects
Time Factors
Treatment Outcome
United Kingdom
Ventricular Function, Left drug effects
Cardiomyopathy, Dilated drug therapy
Cardiovascular Agents therapeutic use
Energy Metabolism drug effects
Heart Failure drug therapy
Myocardium metabolism
Perhexiline therapeutic use
Research Design
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 12
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 21645332
- Full Text :
- https://doi.org/10.1186/1745-6215-12-140