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Metabolic Manipulation in Chronic Heart Failure

NCT ID: NCT00841139

Last Updated: 2011-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Perhexiline maleate is an antianginal agent which increases the efficiency of energy production by shifting substrate utilisation from free fatty acids towards glucose. We showed that perhexiline therapy was highly effective in improving exercise capacity, symptoms and cardiac function in patients with systolic heart failure of both ischaemic and non ischaemic aetiology. Perhexiline acts by inhibiting both carnitine palmitoyl transferase-1 (CPT-1) and CPT-2, which are key enzymes in mitochondrial free fatty acid uptake. This leads to increased myocardial glucose substrate utilization. Further we wish to ascertain whether or not this drug improves cardiac energetics and efficiency by altering substrate utilization. In this proposal we will assess the cardiac function (by cardiac Magnetic Resonance Imaging MRI), cardiac energetic status (by cardiac Magnetic Resonance Spectroscopy MRS), cardiac efficiency (via pressure-volume loops) and substrate utilization (via left and right heart catheterization), following one month of perhexiline therapy or placebo in patients with symptomatic idiopathic dilated cardiomyopathy on optimal conventional heart failure medications. An interim analysis is planned after 20 patients.

Conditions

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Chronic Heart Failure

Keywords

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perhexiline idiopathic dilated cardiomyopathy magnetic resonance spectroscopy cardiac energetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Perhexiline

perhexiline 100mg bd for 1 month duration

Group Type EXPERIMENTAL

Perhexiline

Intervention Type DRUG

100mg o bd

Placebo

placebo one tablet bd for 1 month duration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet bd

Interventions

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Perhexiline

100mg o bd

Intervention Type DRUG

Placebo

1 tablet bd

Intervention Type DRUG

Other Intervention Names

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Pexsig

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Heart Foundation

OTHER

Sponsor Role collaborator

University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Roger Beadle

Research Fellow to Professor MP Frenneaux

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael P Frenneaux, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Roger M Beadle, MBBS

Role: STUDY_DIRECTOR

University of Birmingham

Locations

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University Hospitals Brimingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Site Status

University of Birmingham

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25650370 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21645332 (View on PubMed)

Other Identifiers

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MREC: 06/Q2707/7

Identifier Type: OTHER

Identifier Source: secondary_id

R&D Birminham: RRK 2785

Identifier Type: OTHER

Identifier Source: secondary_id

MHRA: 21761/0003/001

Identifier Type: OTHER

Identifier Source: secondary_id

2004-004965-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2004-004965-14

Identifier Type: -

Identifier Source: org_study_id