Copyright © 1999 by the European Society of Cardiology.
Study on propionyl-L-carnitine in chronic heart failure
accepted July 29, 1998
Abstract
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<0·01). There were no safety issues.
Conclusion
The study fails to meet the primary objective, but confirms the good safety profile of propionyl-L-carnitine. An exploratory non-prespecified analysis suggests that propionyl-L-carnitine improves exercise capacity in patients with preserved cardiac function. This hypothesis needs to be confirmed by a specific tailored study.
Key Words: Chronic heart failure, propionyl-L-carnitine, bicycle exercise test, maximum exercise duration, ejection fraction
Correspondence: Prof. Roberto Ferrari, Cattedra di Cardiologia, Universita’ di Brescia, c/o Spedali Civili, P.le Spedali Civili, 1, 25123 Brescia, Italy.
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