Perhexiline Therapy in Patients With Hypertrophic Cardiomyopathy
METAL-HCM
Metabolic Alteration With Perhexiline Therapy in Patients With Hypertrophic Cardiomyopathy (METAL-HCM Study)
2 other identifiers
interventional
44
1 country
3
Brief Summary
Hypertrophic Cardiomyopathy (HCM) is a relatively common inherited heart muscle disease. Many patients experience symptoms of breathlessness, fatigue and chest pain. These symptoms are not always controlled with current therapies. Recently the investigators showed that a drug called Perhexiline markedly improved exercise capacity and symptoms in patients with heart failure. In this proposal the investigators wish to test whether Perhexiline improves exercise capacity and relieves symptoms in patients with HCM
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2006
Typical duration for phase_2
3 active sites
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
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 10, 2007
CompletedFirst Posted
Study publicly available on registry
July 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedNovember 4, 2010
August 1, 2010
3.7 years
July 10, 2007
November 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak oxygen consumption (Vo2max)
3-4 months
Secondary Outcomes (4)
LV function (TDI and 2DS Echo)
3-4 months
Symptomatic Status (questionnaire)
3-4 months
Resting myocardial energetics (31P Cardiac MR Spectroscopy)
3-4 months
Diastolic function at rest and during exercise (Nuclear studies)
3-4 months
Interventions
Eligibility Criteria
You may qualify if:
- Symptomatic Hypertrophic Cardiomyopathy patients
- Abnormal Peak VO2
- No significant LVOT obstruction at rest (gradient \< 30mmHg)
- Sinus rhythm
You may not qualify if:
- Abnormal LFT.
- Concomitant use of amiodarone
- Pre-existing evidence of peripheral neuropathy.
- Women of childbearing potential.
- Patients with ICD's will be excluded from the MR part of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Birminghamlead
- British Heart Foundationcollaborator
- University College London Hospitalscollaborator
- University of Oxfordcollaborator
Study Sites (3)
heart Hospital, University College of London NHS
London, London, W1G 8PH, United Kingdom
University of Birmingham
Birmingham, West Midlands, B15 2TT, United Kingdom
University of Oxford
Oxford, OX3 9DU, United Kingdom
Related Publications (1)
Abozguia K, Elliott P, McKenna W, Phan TT, Nallur-Shivu G, Ahmed I, Maher AR, Kaur K, Taylor J, Henning A, Ashrafian H, Watkins H, Frenneaux M. Metabolic modulator perhexiline corrects energy deficiency and improves exercise capacity in symptomatic hypertrophic cardiomyopathy. Circulation. 2010 Oct 19;122(16):1562-9. doi: 10.1161/CIRCULATIONAHA.109.934059. Epub 2010 Oct 4.
PMID: 20921440DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Frenneaux, MD
University of Birmingham
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 10, 2007
First Posted
July 12, 2007
Study Start
December 1, 2006
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
November 4, 2010
Record last verified: 2010-08