Recruiting

Amlodipine with Iron Chelation

Sponsor:

Kevin H.M. Kuo, MD, MSc, FRCPC

Code:

NCT02474420

Conditions

Beta-Thalassemia

Iron Overload

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amlodipine

Deferasirox

Study Details

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.

Conditions

Beta-Thalassemia

Iron Overload

Study ID

NCT02474420

Start date

Jun, 2015

Status verified date

Oct, 2016

Completion date

Jun, 2018

Anticipated

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Deferasirox

deferasirox iron chelation therapy and standard of care by the treating physician

experimental: Deferasirox plus amlodipine

deferasirox iron chelation therapy with amlodipine

Interventions

Amlodipine

amlodipine titrated up to 10 mg daily or maximum tolerated dose, whichever comes first

Deferasirox

Deferasirox administered per standard of care by the treating physician

Primary outcome measure

  • Change in cardiac T2* [ Time Frame: 12 months following randomization ]

Central Contacts and Locations

Central contacts

Rebecca Leroux, RN, CCRP

+1-416-715-6485rebecca.leroux@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Rebecca Leroux, RN, CCRP

+1-416-715-6485rebecca.leroux@uhn.ca

Principal Investigator:

Kevin Kuo, MD, MSc, FRCPC

More Information

Sponsor

Kevin H.M. Kuo, MD, MSc, FRCPC

Last update posted

Oct 26, 2016

Last verified

Oct, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kevin H.M. Kuo, MD, MSc, FRCPC on 2016-10-26.