Study on propionyl-L-carnitine in chronic heart failure

Aims In patients with chronic heart failure, fatigue is independent of haemodynamic and neuroendocrine changes and possibly may be due to impaired muscle metabolism. Propionyl-L-carnitine, a carnitine derivative, was shown in previous studies to improve muscle metabolism. The objective of this study...

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Bibliographic Details
Published in:European heart journal 1999-01, Vol.20 (1), p.70-76
Format: Article
Language:English
Subjects:
Angiotensin-Converting Enzyme Inhibitors - therapeutic use
bicycle exercise test
Cardiotonic Agents - therapeutic use
Carnitine - analogs & derivatives
Carnitine - therapeutic use
Chronic Disease
Chronic heart failure
Diuretics - therapeutic use
Double-Blind Method
Drug Therapy, Combination
ejection fraction
Exercise Test
Female
Follow-Up Studies
Heart Failure - drug therapy
Heart Failure - mortality
Heart Failure - physiopathology
Humans
Male
maximum exercise duration
Middle Aged
propionyl-L-carnitine
Quality of Life
Retrospective Studies
Stroke Volume - drug effects
Survival Rate
Treatment Outcome
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Summary:Aims In patients with chronic heart failure, fatigue is independent of haemodynamic and neuroendocrine changes and possibly may be due to impaired muscle metabolism. Propionyl-L-carnitine, a carnitine derivative, was shown in previous studies to improve muscle metabolism. The objective of this study was to evaluate the effect of propionyl-L-carnitine on exercise capacity in mild–moderate chronic heart failure patients, treated with ACE inhibitors and diuretics. Methods and Results This was a phase III, double-blind, randomized, parallel, multicentre study. The primary objective was the evaluation of the effect of propionyl-L-carnitine vs placebo on maximum exercise duration using a bicycle exercise test. The primary analysis performed in the intention-to-treat population (271 and 266 patients in propionyl-L-carnitine and placebo), showed no statistically significant difference between treatments. A difference of 15s in favour of propionyl-L-carnitine was observed in the completer/complier population (P=0·092). An a priori specified subgroup analysis on patients stratified by baseline maximum exercise duration showed a trend of improvement in propionyl-L-carnitine patients with shorter maximum exercise duration. A non a priori specified analysis in patients stratified by ejection fraction (≤30% vs 30–40%), showed a statistically significant difference in maximum exercise duration in favour of propionyl-L-carnitine in those patients with a higher ejection fraction (40s,P
ISSN:0195-668X
1522-9645
DOI:10.1053/euhj.1998.1271