Amlodipine Use in the Prevention and Treatment of Iron Ov... | NCT01125254

Studies
Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major

NCT01125254

Sponsor

University of Campinas, Brazil

Status

Completed

Last Update Posted

Jan 5, 2015Estimated

Enrollment

10Actual

Phase

Phase 2Phase 3

Conditions

Thalassemia Major

Interventions

Amlodipine

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

May 13, 2010

First Submission Date that Met QC Criteria

May 17, 2010

First Posted Date

May 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2015

Last Update Posted Date

Jan 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juliano de Lara Fernandes, Research Physician, University of Campinas, BrazilPrincipal Investigator

Lead Sponsor

University of Campinas, BrazilOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. The study will follow 10 patients with thalassemia major: 5 will openly receive amlodipine and 5 will serve as controls, not receiving any additional drugs. Patients will be monitored through one year with an additional year of follow up after the group using amlodipine stops its use. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2* by MRI.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amlodipine	Experimental	amlodipine 5mg qd	Drug: Amlodipine
Controls	Placebo Comparator	placebo	Drug: Amlodipine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amlodipine	Drug	5mg po for 12 months	Amlodipine Controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Myocardium T2*	Heart T2* by MRI at 12 months	12 months

Secondary Outcomes

Measure	Description	Time Frame
Liver T2*	Liver T2* by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.	24 months
Heart volumes	Diastolic and systolic volumes by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with thalassemia major over 6 years of age in use of iron chelating therapy.

Exclusion Criteria:

pregnancy;
advanced heart failure with NYHA III/IV or LVEF < 35%;
formal contra-indications to an MRI study;
patient with advanced heart block.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juliano L Fernandes, MD	University of Campinas, Brazil	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Campinas		Campinas	São Paulo	13100	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37975597	Derived	Padhani ZA, Gangwani MK, Sadaf A, Hasan B, Colan S, Alvi N, Das JK. Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia. Cochrane Database Syst Rev. 2023 Nov 17;11(11):CD011626. doi: 10.1002/14651858.CD011626.pub3.

ID	Term
D013789	Thalassemia
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds