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Amlodipine as Adjuvant Treatment to Iron Chelation for Prevention of Cardiac Iron Overload in Thalassemia Patients (CANALI)

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ClinicalTrials.gov Identifier: NCT02474420
Recruitment Status : Unknown
Verified October 2016 by Kevin H.M. Kuo, MD, MSc, FRCPC, University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : June 17, 2015
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Kevin H.M. Kuo, MD, MSc, FRCPC, University Health Network, Toronto

Study Description
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Brief Summary:
This is a randomized, open label, two arms superiority trial of a representative population of patients with a primary diagnosis of transfusion dependent thalassemia with evidence of moderate cardiac iron overload, defined as an average T2* MRI parameter at the mid inter-ventricular septum between 10 and 20ms.

Condition or disease Intervention/treatment Phase
Beta-Thalassemia Iron Overload Drug: Amlodipine Drug: Deferasirox Not Applicable

Detailed Description:

Selection of Study Population: The study will enroll 60 adult subjects with transfusion dependent thalassemia receiving deferasirox iron chelation therapy. All eligible subjects will be asked to provide informed consent before participating in the study.

Randomization: Subjects will be randomized in a 1:1 ratio to either continuation of their DFX (control arm) or a combination of DFX plus amlodipine (amlodipine arm).

Treatment: Subjects randomized to the amlodipine arm will receive open label medication (amlodipine) starting at 2.5mg/day and up-titrated by 2.5mg every 7-14 days with the goal of reaching 10mg/day. DFX dose in either arm will not be adjusted unless it was deemed unsafe to remain on the same dose of DFX by the treating physician (significant side effects, lack of efficacy or over-chelation) or T2* drops below 8 ms.

Safety Assessment: Weekly or fortnightly amlodipine titration will be conducted by the research physician in-clinic, based on blood pressure, tolerability, and presence or absence of side-effects.

Adverse Events will be assessed at every visit after the first dose through to the last subject visit.

Efficacy Assessment: the efficacy of amlodipine combined to standard chelation therapy will be assessed by cardiac T2*MRI, done at baseline and 12 months post treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of the Calcium Channel Blocker Amlodipine as an Adjuvant Treatment to Iron Chelation for the Prevention of Iron Overload Cardiomyopathy in Patients With Thalassemia
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Thalassemia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Deferasirox
deferasirox iron chelation therapy and standard of care by the treating physician
 Drug: Deferasirox
Deferasirox administered per standard of care by the treating physician
Experimental: Deferasirox plus amlodipine
deferasirox iron chelation therapy with amlodipine
 Drug: Amlodipine
amlodipine titrated up to 10 mg daily or maximum tolerated dose, whichever comes first

Drug: Deferasirox
Deferasirox administered per standard of care by the treating physician


Outcome Measures
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Primary Outcome Measures :
  1. Change in cardiac T2* [ Time Frame: 12 months following randomization ]
    Change in cardiac T2* as determined by MRI


Secondary Outcome Measures :
  1. Change in left ventricular ejection fraction [ Time Frame: 12 months following randomization ]
    Change in left ventricular ejection fraction (in %) as determined by MRI

  2. Number of Participants with Adverse Events [ Time Frame: 12 months following randomization ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of transfusion-dependent Thalassemia being followed by a thalassemia comprehensive care clinic Age 18 or older
  • Taking deferasirox and on a stable dose for >3 months
  • Evidence on cardiac MRI of mild to moderate cardiac iron overload (T2*<20ms but ≥10ms) as measured within 3 months prior to randomization. If a recent cardiac MRI has not been obtained, patients who otherwise meet all eligibility criteria and provide appropriate consent will undergo a cardiac MRI to confirm eligibility
  • Preserved left ventricular ejection fraction (LVEF) >55% as measured by cardiac MRI. If a recent cardiac MRI has not been obtained, patients who otherwise meet all eligibility criteria and provide appropriate consent will undergo a cardiac MRI to confirm eligibility.
  • Agreeable to use an approved method of contraception if female of childbearing potential for the entire duration of the study.

Exclusion Criteria:

  • Serum ferritin < 500 ng/mL at screening
  • Liver iron concentration > 30 mg/g dw as measured by liver R2 MRI (FerriScan)
  • Congestive heart failure
  • Severe refractory Hypotension (less than 90 mmHg systolic)
  • Currently taking any calcium channel blockers
  • Pregnancy or nursing (a negative HCG (pregnancy) test must be obtained prior to randomization)
  • As a result of medical review, physical examination or screening investigations, the Principal Investigator (PI) considers the subject unfit for the study
  • No fixed address
  • Hypersensitivity to amlodipine or other dihydropyridines
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474420


Contacts
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Contact: Rebecca Leroux, RN, CCRP +1-416-715-6485 rebecca.leroux@uhn.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Rebecca Leroux, RN, CCRP    +1-416-715-6485    rebecca.leroux@uhn.ca   
Principal Investigator: Kevin Kuo, MD, MSc, FRCPC         
Sponsors and Collaborators
Kevin H.M. Kuo, MD, MSc, FRCPC
Investigators
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Principal Investigator: Kevin HM Kuo, MD MSc FRCPC University Health Network, Toronto
More Information
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Responsible Party: Kevin H.M. Kuo, MD, MSc, FRCPC, Assistant Professor, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02474420    
Other Study ID Numbers: CANALI
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Amlodipine
 Deferasirox
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Iron Chelating Agents
Chelating Agents
Sequestering Agents