NCT00839228

Brief Summary

Up to half of all patients with clinical features of heart failure are found to have normal heart pumping function. Recently the investigators have shown that a drug called perhexiline markedly improved exercise capacity and symptoms in patients with heart failure associated with impaired cardiac pump function. In this proposal the investigators will assess whether perhexiline has beneficial effects in patients with heart failure and a normal heart pumping function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

4.9 years

First QC Date

February 6, 2009

Last Update Submit

November 4, 2015

Conditions

Diastolic Heart Failure

Keywords

diastolic dysfunctioncardiac energeticsperhexilinemagnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Change in Peak oxygen consumption (Vo2max)

    3 months

Secondary Outcomes (5)

  • Symptomatic Status (Modified Minnesota Living with Heart Failure Questionnaire)

    3 Months

  • Resting myocardial energetics by cardiac MR spectroscopy (MRS)

    3 months

  • Resting and exercise diastolic function (nuclear studies)

    3 months

  • Indirect measures of resting LVEDP (tissue Doppler E/Ea)

    3 months

  • Global LV Ejection Fraction (MRI / nuclear studies)

    3 months

Study Arms (2)

Perhexiline

EXPERIMENTAL

perhexiline 100mg o bd for 3 months

Drug: Perhexiline

Placebo

PLACEBO COMPARATOR

Placebo one tablet bd for 3 months

Drug: Placebo

Interventions

PerhexilineDRUG

100mg o bd for 3 months

Also known as: Pexsig
Perhexiline
PlaceboDRUG

Placebo one tablet bd for 3 months

Also known as: Starch Placebo
Placebo

Eligibility Criteria

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

You may qualify if:

  • HFpEF will be defined as:
  • Clinical features consistent with heart failure
  • LVEF ≥ 50%, with no evidence of significant valvular disease
  • No hypertrophic cardiomyopathy, and no evidence of pericardial constriction
  • Peak VO2 \< 80% predicted, with RER\>1 and with a pattern of gas exchange on metabolic exercise testing indicating a cardiac cause for limitation)
  • Patients recruited will be in sinus rhythm

You may not qualify if:

  • BMI \>35
  • Objective evidence of lung disease on formal lung function testing
  • Reversible myocardial ischaemia on contrast-enhanced myocardial stress Echocardiography, and no evidence of exercise-induced mitral regurgitation (\>2+)
  • Impaired hepatic function; known hypersensitivity to perhexiline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen

Aberdeen, AB25 2ZD, United Kingdom

Location

Related Publications (1)

  • Singh S, Beadle R, Cameron D, Rudd A, Bruce M, Jagpal B, Schwarz K, Brindley G, Mckiddie F, Lang C, Dawson D, Frenneaux M. Randomized double-blind placebo-controlled trial of perhexiline in heart failure with preserved ejection fraction syndrome. Future Cardiol. 2014 Nov;10(6):693-8. doi: 10.2217/fca.14.62.

    PMID: 25495811DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Perhexiline

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael P Frenneaux, MBBS MD

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 9, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

GB(1)