Study on propionyl-L-carnitine in chronic heart failure

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#angiotensin-converting-enzyme-inhibitors #cardiotonic-agents #carnitine #chronic-disease #diuretics

Study on propionyl-L-carnitine in chronic heart failure

Unknown et al., 1999 | Eur Heart J | Rct

Citation

. Study on propionyl-L-carnitine in chronic heart failure. Eur Heart J. 1999-Jan;20(1):70-6

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 15 s 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 (< or = 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 (40 s, 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 Findings

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 15 s in favour of propionyl-L-carnitine was observed in the

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population chronic heart failure
Sample Size 266
Age Range See abstract
Condition See abstract

MeSH Terms

  • Angiotensin-Converting Enzyme Inhibitors
  • Cardiotonic Agents
  • Carnitine
  • Chronic Disease
  • Diuretics
  • Double-Blind Method
  • Drug Therapy, Combination
  • Exercise Test
  • Female
  • Follow-Up Studies
  • Heart Failure
  • Humans
  • Male
  • Middle Aged
  • Quality of Life
  • Retrospective Studies
  • Stroke Volume
  • Survival Rate
  • Treatment Outcome

Evidence Classification

  • Level: Rct
  • Publication Types: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
  • Vertical: carnitine-cardiovascular

Provenance

  • PMID: 10075143
  • DOI: (not available)
  • PMCID: Not in PMC
  • Verified: 2026-04-09 via PubMed E-utilities API

Source extracted via PubMed E-utilities API on 2026-04-09