Status:
UNKNOWN
Role of Perhexiline in Hypertrophic Cardiomyopathy
Lead Sponsor:
Flinders University
Conditions:
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Hypertrophic Cardiomyopathy (HCM) is the most common inherited heart muscle condition affecting up to 1 in 200 of the general population. It results from mutations in genes encoding components of the ...
Eligibility Criteria
Inclusion
- Left Ventricular Ejection Fraction (LVEF) =/\> 55% by echocardiography or CMR during the screening period or within 6 months prior to study entry
- Current / prior symptom(s) of HCM (New York Heart Association \[NYHA\] functional class II or class III, Canadian Cardiovascular Society \[CCS\] grade II or grade III) and requiring treatment with ß-blockers and /or non-dihydropyridine calcium antagonists and / or disopyramide for at least 30 days prior to study entry
- Structural heart disease as evidenced by interventricular septal thickness of (= 15 mm) on echocardiography or CMR in the absence of abnormal loading conditions
- Elevated N terminal pro-brain natriuretic peptide (NT-proBNP), \>125 pg/ml
Exclusion
- Any prior echocardiographic or CMR measurement of LVEF \<55%
- Current acute decompensated heart failure requiring hospitalisation and / or augmented medical therapy
- Cardiac surgery or catheter-based septal reduction therapy planned or having occurred within the past 1 year
- Patients with a non-CMR conditional pacemaker / implantable cardioverter-defibrillator device
- History of a known chronic liver disease, peripheral neuropathy, recurrent hypoglycemia
- Serum bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or lactate dehydrogenase \> 2.0 times upper limit of normal
- Previous adverse reaction to perhexiline at therapeutic plasma levels of the drug
- Concomitant use of amiodarone, ranolazine or trimetazidine
- Life-threatening or uncontrolled dysrhythmia
- Contraindications to CMR, gadolinium, adenosine
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04426578
Start Date
December 1 2020
End Date
August 1 2022
Last Update
March 11 2021
Active Locations (1)
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1
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042