Metabolic manipulation in chronic heart failure: study protocol for a randomised controlled trial
2011

Study Protocol for Metabolic Manipulation in Heart Failure

Sample size: 50 publication Evidence: moderate

Author Information

Author(s): Beadle Roger M, Williams Lynne K, Abozguia Khaild, Patel Kiran, Leon Francisco Leyva, Yousef Zaheer, Wagenmakers Anton, Frenneaux Michael P

Primary Institution: University of Aberdeen

Hypothesis

Treatment with perhexiline increases cardiac PCr/ATP ratio, increases cardiac respiratory quotient, and improves LV mechanical efficiency and left ventricular function in patients with dilated cardiomyopathy.

Conclusion

The study aims to determine if perhexiline can improve cardiac energetics in patients with heart failure.

Supporting Evidence

  • Heart failure is a major cause of morbidity and mortality.
  • Current therapies focus on neurohormonal modulation.
  • Energy deficiency is a key issue in heart failure.
  • Perhexiline may improve cardiac energy status.

Takeaway

This study is trying to see if a medicine called perhexiline can help hearts work better in people who have heart failure.

Methodology

A multicentre, prospective, randomised double-blind, placebo-controlled trial with 50 subjects receiving either perhexiline or placebo for 4 weeks.

Potential Biases

Potential risks include unmonitored perhexiline levels leading to hepatotoxicity and peripheral neuropathy.

Limitations

The study may be underpowered for the secondary endpoint of improvement in LV function.

Participant Demographics

Participants are adults with non-ischaemic dilated cardiomyopathy and impaired left ventricular function.

Statistical Information

P-Value

< 0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1745-6215-12-140

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