Trientine in Hypertrophic Cardiomyopathy

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2014-001577-13-GB
• Date of registration: 04/06/2014
• Prospective Registration: Yes
• Primary sponsor: Manchester University NHS Foundation Trust
• Public title: Trientine in Hypertrophic Cardiomyopathy
• Scientific title: Copper Chelation in Hypertrophic Cardiomyopathy: Open-label pilot study of Trientine in patients with hypertrophic cardiomyopathy - Copper (II) Chelation therapy in the treatment of HCM
• Date of first enrolment: 15/07/2014
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001577-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Anna Reid
• Affiliation: Manchester University NHS Foundation Trust

• Name: Anna Reid
• Affiliation: Manchester University NHS Foundation Trust

Key inclusion & exclusion criteria

Inclusion criteria:
• Male or female > 18 years of age
• Females will be non-pregnant and non-lactating with no intention of pregnancy during study
treatment
• Confirmed diagnosis of HCM in line with 2011 ACCF / AHA consensus document • ?-myosin heavy chain genotype
• Asymmetric septal hypertrophy-type HCM phenotype
• LV ejection fraction = 50%

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion criteria:
• History of any other cardiovascular disorder, including aortic stenosis, aortic coarctation, hypertension, renal artery stenosis, atrial fibrillation
• NYHA Class III / IV heart failure
• Diabetes Mellitus
• Contraindication to magnetic resonance imaging (MRI) scanning (including claustrophobia)
• Known hypersensitivity to Trientine or excipients
• Known hypersensitivity to Gadolinium-based contrast agent
• eGFR < 50ml/min/1.73m2
• BMI > 40kg/m2
• History of significant malabsorption
• Copper deficiency at baseline
• Iron deficiency at baseline
• Haemoglobin < 10g/dL
• Unresolved haematological disorder
• Severe hepatic impairment
• Untreated thyroid disease
• Autoimmune disorders/connective tissue disease
• Drug or alcohol abuse
• Pregnancy/breast-feeding. Women of childbearing potential (not >2 years post- menopausal
and/or not surgically sterilised) must have a negative blood serum pregnancy test, performed at visit 1 prior to administration of study medication
• Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient’s ability to participate in the study
• Any other condition, which in the opinion of the research team, may put participants at risk during the study, or which may affect the outcome of the study
• New medication within the preceding month of the study (excluding short term prescriptions)
• Participation in another study involving an investigational product in the previous 12 weeks


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Hypertrophic Cardiomyopathy
MedDRA version: 20.0 Level: PT Classification code 10020871 Term: Hypertrophic cardiomyopathy System Organ Class: 10010331 - Congenital, familial and genetic disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Trade Name: Trientine dihydrochloride
Product Name: Trientine dihydrochloride
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Trientine Dihydrochloride
CAS Number: 38260-01-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: This end-point will be evaluated after 6 months of treatment

Secondary Objective: ii. Does Trientine lead to reduction in left ventricular (LV) i.e. heart muscle mass in patients with HCM?
iii. Does Trientine lead to an improvement in myocardial fibrosis (heart muscle scarring) in HCM?
iv. Does Trientine lead to improved exercise capacity in patients with HCM?

Main Objective: i. Does Trientine lead to an improvement in high-energy phosphate metabolism (myocardial energetics, i.e. energy processing) in patients with HCM?

Primary end point(s): To evaluate the change in myocardial energetics, as measured using cardiac MRI, in patients with HCM after treatment with Trientine.

Secondary Outcome(s)

Secondary end point(s): ii. Does Trientine lead to reduction in left ventricular (LV) mass in patients with HCM?
iii. Does Trientine lead to an improvement in myocardial fibrosis in HCM?
iv. Does Trientine lead to improved exercise capacity in patients with HCM?

Timepoint(s) of evaluation of this end point: These end-point will be evaluated after 6 months of treatment

Secondary ID(s)

CC-HCM-01

Source(s) of Monetary Support

Medical Research Council

Univar

Ethics review

Status: Approved
Approval date:
Contact: