Thalassemia MajorPhase 2/3AnloThalNCT01125254
Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
A Phase 2/3 study testing Amlodipine in people with Thalassemia Major, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 90 years
- Conditions the study is for
- Thalassemia Major
- What is being tested?
- Amlodipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2008to Jul 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with thalassemia major over 6 years of age in use of iron chelating therapy.
Who cannot join
- pregnancy;
- advanced heart failure with NYHA III/IV or LVEF < 35%;
- formal contra-indications to an MRI study;
- patient with advanced heart block.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Thalassemia Major
- Being tested
- Amlodipine
- Keywords
- thalassemia major, calcium channel blockade, magnetic resonance imaging
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
5mg po for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine | Experimental | amlodipine 5mg qd Receives: Drug: Amlodipine |
| Controls | Placebo comparator | placebo Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardium T2*
Heart T2* by MRI at 12 months
Measured: 12 months
Secondary outcomes (5)
Liver T2*
Liver T2* by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Measured: 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.
Measured: 24 months
Left ventricle ejection fraction
LVEF by MRI every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Measured: 24 months
Serum ferritin
Serum ferritin every 6 months for 2 years. First year with active treatment; second year with withdrawal.
Measured: 24 months
Myocardium T2*
Heart T2* by MRI every 6 months until 24 months
Measured: 6-18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startSep 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thalassemia MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Juliano de Lara Fernandes, University of Campinas, Brazil
- Investigators
- Juliano L Fernandes, MD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125254
- Sponsor's protocol ID
- 000002
- Acronym
- AnloThal
- Status last verified
- Jan 2015
- First submitted
- 13 May 2010
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37975597
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
- ClinicalTrials.gov ID
- NCT01125254
- Acronym / sponsor ID
- AnloThal / 000002
- Conditions
- Thalassemia Major
- Keywords
- thalassemia major, calcium channel blockade, magnetic resonance imaging
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlodipine | Experimental | Drug: Amlodipineamlodipine 5mg qd |
| Controls | Placebo comparator | Drug: Amlodipineplacebo |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with thalassemia major over 6 years of age in use of iron chelating therapy.
Key exclusion criteria (4 listed)
- pregnancy;
- advanced heart failure with NYHA III/IV or LVEF < 35%;
- formal contra-indications to an MRI study;
- patient with advanced heart block.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine5mg po for 12 months | Drug | Amlodipine, Controls |
Primary outcome
Myocardium T2*
Time frame: 12 months
Heart T2* by MRI at 12 months
5 secondary outcomes
Liver T2*
Time frame: 24 months
Heart volumes
Time frame: 24 months
Left ventricle ejection fraction
Time frame: 24 months
Serum ferritin
Time frame: 24 months
Myocardium T2*
Time frame: 6-18-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Derived from this study: PubMed 37975597Padhani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliano L Fernandes, MD principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amlodipine in people with Thalassemia Major, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardium T2* (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01125254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2015.