B ThalassemiaPhase 2/3NCT01863173
Effect of Metoprolol on Thalassemia Cardiomyopathy
A Phase 2/3 study testing metoprolol in people with B Thalassemia, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
effect of B blocker was first evaluated in patient with cardiomyopathy not induced by ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on Thalassemia cardiomyopathy was evaluated in this study Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- B Thalassemia
- What is being tested?
- metoprolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIran
- Study dates
- Jan 2012to Dec 2012
- 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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- documented LVEF < 50% by echocardiography
- B thalassemia
- No decompensated heart failure for at least 4 weeks (hospitalization for CHF, worsening lower extremity edema, worsening dyspnea on exertion, , and orthopnea)
- have no evidence of acute myocarditis and
- hemoglobin level above 7 gr⁄dL.
Who cannot join
- pulse rate below 60/min
- systolic blood pressure less than 90 mmHg
- evidence of peripheral vascular disease
- major depression, history of asthma, PR interval more than 240 msec, second or third degree AV block
- major medical diseases including diabetes mellitus requiring insulin injection, hypothyroidism, hypoparathyroidism, chronic renal failure (glomerular filtration rate below 30 ml/min), hepatic cirrhosis, hepatitis-B and hepatitis-C, positive tests for human immunodeficiency virus, and other hemoglobinopathies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Metoprolol Succinate on the Cardiac Function of Patients With Thalassemia Cardiomyopathy a Double Blind Randomized Study
effect of B blocker was first evaluated in patient with cardiomyopathy not induced by ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on Thalassemia cardiomyopathy was evaluated in this study
Read the detailed description
In this clinical trial, 45 patients with thalassemia cardiomyopathy were randomized to receive either metoprolol (n = 26) or placebo (n = 19). Echocardiography and 6 minute walk test was performed at baseline and repeated after 6 months and the values were compared.
- Conditions
- B Thalassemia
- Being tested
- metoprolol, placebo
- Keywords
- Thalassemia cardiomyopathy, metoprolol succinate, echocardiography, six minute walk test
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metoprololDrug
using B blocker in patient group
placeboDrug
placebo to control group
| Study group | Role | What they receive |
|---|---|---|
| metoprolol | Active comparator | patient or intervention group Receives: Drug: metoprolol |
| placebo group | Active comparator | control group Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ejection fraction
LV contractility
Measured: 6 months
6 minutes walk test
functional capacity
Measured: 6 months
endsystolic volume
functional capacity
Measured: 6 months
Secondary outcomes (1)
patient compliance
drug complication,
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for B ThalassemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863173
- Sponsor's protocol ID
- 91-3502
- Status last verified
- May 2013
- First submitted
- 18 May 2013
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Atiq M, Bana M, Ahmed US, Bano S, Yousuf M, Fadoo Z, Khurshid M. Cardiac disease in beta-thalassaemia major: Is it reversible? Singapore Med J. 2006 Aug;47(8):693-6.
PubMed 16865210Murphy CJ, Oudit GY. Iron-overload cardiomyopathy: pathophysiology, diagnosis, and treatment. J Card Fail. 2010 Nov;16(11):888-900. doi: 10.1016/j.cardfail.2010.05.009. Epub 2010 Jul 3.
PubMed 21055653Kojury J, Zolghadrasli A, Karimi M, Babaee Beighi MA, Namazi S. The effect of metoprolol succinate on the cardiac function of patients with thalassaemia cardiomyopathy: a double-blind randomised study. Heart Asia. 2014 Apr 17;6(1):54-8. doi: 10.1136/heartasia-2013-010460. eCollection 2014.
PubMed 27326168
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metoprolol Succinate on the Cardiac Function of Patients With Thalassemia Cardiomyopathy a Double Blind Randomized Study
- ClinicalTrials.gov ID
- NCT01863173
- Acronym / sponsor ID
- 91-3502
- Conditions
- B Thalassemia
- Keywords
- Thalassemia cardiomyopathy, metoprolol succinate, echocardiography, six minute walk test
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 May 2013 (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.
effect of B blocker was first evaluated in patient with cardiomyopathy not induced by ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on Thalassemia cardiomyopathy was evaluated in this study
Detailed description
In this clinical trial, 45 patients with thalassemia cardiomyopathy were randomized to receive either metoprolol (n = 26) or placebo (n = 19). Echocardiography and 6 minute walk test was performed at baseline and repeated after 6 months and the values were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metoprolol | Active comparator | Drug: metoprololpatient or intervention group |
| placebo group | Active comparator | Drug: placebocontrol group |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- documented LVEF < 50% by echocardiography
- B thalassemia
- No decompensated heart failure for at least 4 weeks (hospitalization for CHF, worsening lower extremity edema, worsening dyspnea on exertion, , and orthopnea)
- have no evidence of acute myocarditis and
- hemoglobin level above 7 gr⁄dL.
Key exclusion criteria (5 listed)
- pulse rate below 60/min
- systolic blood pressure less than 90 mmHg
- evidence of peripheral vascular disease
- major depression, history of asthma, PR interval more than 240 msec, second or third degree AV block
- major medical diseases including diabetes mellitus requiring insulin injection, hypothyroidism, hypoparathyroidism, chronic renal failure (glomerular filtration rate below 30 ml/min), hepatic cirrhosis, hepatitis-B and hepatitis-C, positive tests for human immunodeficiency virus, and other hemoglobinopathies
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 |
|---|---|---|
| metoprololusing B blocker in patient group | Drug | metoprolol |
| placeboplacebo to control group | Drug | placebo group |
Primary outcome
ejection fraction
Time frame: 6 months
LV contractility
6 minutes walk test
Time frame: 6 months
functional capacity
endsystolic volume
Time frame: 6 months
functional capacity
1 secondary outcome
patient compliance
Time frame: 6 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 27 May 2013.
- Background: PubMed 16865210Atiq M, Bana M, Ahmed US, Bano S, Yousuf M, Fadoo Z, Khurshid M. Cardiac disease in beta-thalassaemia major: Is it reversible? Singapore Med J. 2006 Aug;47(8):693-6.
- Background: PubMed 21055653Murphy CJ, Oudit GY. Iron-overload cardiomyopathy: pathophysiology, diagnosis, and treatment. J Card Fail. 2010 Nov;16(11):888-900. doi: 10.1016/j.cardfail.2010.05.009. Epub 2010 Jul 3.
- Derived from this study: PubMed 27326168Kojury J, Zolghadrasli A, Karimi M, Babaee Beighi MA, Namazi S. The effect of metoprolol succinate on the cardiac function of patients with thalassaemia cardiomyopathy: a double-blind randomised study. Heart Asia. 2014 Apr 17;6(1):54-8. doi: 10.1136/heartasia-2013-010460. eCollection 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 metoprolol in people with B Thalassemia, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 5 inclusion and 5 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 27 May 2013. 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 Iran. 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. 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?
ejection fraction (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT01863173, which also lists 3 linked publications.
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 27 May 2013.