NCT00841139

Brief Summary

Conventional measures used for the treatment of chronic heart failure act predominantly by reducing the work performed by the heart. In a recent study, the investigators showed that one drug (perhexiline) substantially improved symptoms and cardiac function in heart failure. The investigators wish to confirm these findings and test whether or not this drug acts by altering the heart's energy source thus augmenting the energetic status and work efficiency of the heart.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 29, 2011

Status Verified

November 1, 2011

Enrollment Period

2.6 years

First QC Date

February 6, 2009

Last Update Submit

November 25, 2011

Conditions

Chronic Heart Failure

Keywords

perhexilineidiopathic dilated cardiomyopathymagnetic resonance spectroscopycardiac energetics

Outcome Measures

Primary Outcomes (1)

  • Change in cardiac energetics as demonstrated by resting myocardial PCr/ATP ratio from cardiac MRS

    1 Month

Secondary Outcomes (2)

  • Change in mechanical efficiency (external work / MVO2)

    1 Month

  • Change in respiratory quotient

    1 Month

Study Arms (2)

Perhexiline

EXPERIMENTAL

perhexiline 100mg bd for 1 month duration

Drug: Perhexiline

Placebo

PLACEBO COMPARATOR

placebo one tablet bd for 1 month duration

Drug: Placebo

Interventions

PerhexilineDRUG

100mg o bd

Also known as: Pexsig
Perhexiline
PlaceboDRUG

1 tablet bd

Placebo

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Optimally-medicated idiopathic dilated cardiomyopathy
  • Symptomatic ( NYHA IIb-III)
  • Impaired left ventricular systolic function (EF \< 40%)

You may not qualify if:

  • Abnormal liver function tests (defined as above twice the upper limit of normal (ULN))
  • Concomitant use of Amiodarone , Quinidine , Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme.
  • Pre-existing evidence of peripheral neuropathy.
  • Women of childbearing potential.
  • Patients with implantable cardiac devices (or any other contraindication to MRI).
  • Obesity ( BMI \> 32)
  • Obstructive sleep apnea syndrome
  • Patients with known hypersensitivity to perhexiline
  • Patients with impaired renal function (Creatinine \> 250 µmol/L)
  • Valvular heart disease defined as more than moderate valvular stenosis or regurgitation.
  • Atrial Fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospitals Brimingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

University of Birmingham

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

Related Publications (2)

  • Beadle RM, Williams LK, Kuehl M, Bowater S, Abozguia K, Leyva F, Yousef Z, Wagenmakers AJ, Thies F, Horowitz J, Frenneaux MP. Improvement in cardiac energetics by perhexiline in heart failure due to dilated cardiomyopathy. JACC Heart Fail. 2015 Mar;3(3):202-11. doi: 10.1016/j.jchf.2014.09.009. Epub 2015 Jan 28.

    PMID: 25650370DERIVED

  • Beadle RM, Williams LK, Abozguia K, Patel K, Leon FL, Yousef Z, Wagenmakers A, Frenneaux MP. Metabolic manipulation in chronic heart failure: study protocol for a randomised controlled trial. Trials. 2011 Jun 6;12:140. doi: 10.1186/1745-6215-12-140.

    PMID: 21645332DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Perhexiline

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael P Frenneaux, MBBS MD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

  • Roger M Beadle, MBBS

    University of Birmingham

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow to Professor MP Frenneaux

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 11, 2009

Study Start

February 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 29, 2011

Record last verified: 2011-11

Locations

GB(2)