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Perhexiline therapy in patients with heart failure with preserved left ventricular ejection fraction(HFpEF syndrome) - HFpEF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001109-28-GB

Enrollment

Registered

2006-09-18

Start date

2008-05-23

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with preserved left ventricular ejection fraction MedDRA version: 14.1 Level: HLGT Classification code 10019280 Term: Heart failures System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.1 Level: HLT Classification code 10019283 Term: Heart failure signs and symptoms System Organ Class: 10007541 - Cardiac di

Interventions

Trade Name: PERHEXILINE MALEATE Product Name: Perhexiline Maleate Product Code: 021418 Pharmaceutical Form: Tablet INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Clinical features consistant with heart failure LVEF>50%,with no evidence of significant valvular disease, no hypertrophic cardiomyopathy, and no ebvidence of pericardial constriction. A peak VO2 of =65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Abnormal liver function tests, pre-existing peripheral neuropathy, concomitant use of amiodarone and women of childbearing potential, objective evidence of lung disease on formal lung function tests

Design outcomes

Primary

Measure	Time frame
Main Objective: To test whether perhexiline improve exercise capacity (peak vo2) in patients with heart failure with preserved left ventricular ejection fraction(HFpEFsyndrome);Primary end point(s): Peak VO2;Timepoint(s) of evaluation of this end point: 6 months; Secondary Objective: Improvement in : Symptomatic status(modified minnesota living with heart failure questionnaire) Global LV ejection fraction(MRI),long axis systolic function,and radial systolic function(MRI,ECHO,tissure doppler) Peak exercise cardiac output Resting and exercise myocardial energetics by cardiac MR spectroscopy Resting and exercise diastolic function(nuclear studies)	—

Measure

Time frame

Main Objective: To test whether perhexiline improve exercise capacity (peak vo2) in patients with heart failure with preserved left ventricular ejection fraction(HFpEFsyndrome);Primary end point(s): Peak VO2;Timepoint(s) of evaluation of this end point: 6 months; Secondary Objective: Improvement in : Symptomatic status(modified minnesota living with heart failure questionnaire) Global LV ejection fraction(MRI),long axis systolic function,and radial systolic function(MRI,ECHO,tissure doppler) Peak exercise cardiac output Resting and exercise myocardial energetics by cardiac MR spectroscopy Resting and exercise diastolic function(nuclear studies)

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Secondary

Measure	Time frame
Secondary end point(s): Symptomatic status( Modified Minnesota living with heart failure questionnaire) Global LV ejection fraction,long axis systolic function, radial systolic function(MRI, ECHO, tissure doppler) Peak exercise cardiac outputdial resting and exercise myocardial energetics by cardiac MR spectroscopy Resting and exercise diastolic dysfunction(nuclear studies) ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Secondary end point(s): Symptomatic status( Modified Minnesota living with heart failure questionnaire) Global LV ejection fraction,long axis systolic function, radial systolic function(MRI, ECHO, tissure doppler) Peak exercise cardiac outputdial resting and exercise myocardial energetics by cardiac MR spectroscopy Resting and exercise diastolic dysfunction(nuclear studies) ;Timepoint(s) of evaluation of this end point: 6 months

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Countries

United Kingdom

Contacts

Public ContactMichael P Frenneaux

University of Aberdeen

m.p.frenneaux@abdn.ac.uk00441224551943

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026