NCT01863173

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2013

Completed
Last Updated

May 27, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

May 18, 2013

Last Update Submit

May 22, 2013

Conditions

B Thalassemia

Keywords

Thalassemia cardiomyopathymetoprolol succinateechocardiographysix minute walk test

Outcome Measures

Primary Outcomes (3)

  • ejection fraction

    LV contractility

    6 months

  • 6 minutes walk test

    functional capacity

    6 months

  • endsystolic volume

    functional capacity

    6 months

Secondary Outcomes (1)

  • patient compliance

    6 months

Study Arms (2)

metoprolol

ACTIVE COMPARATOR

patient or intervention group

Drug: metoprolol

placebo group

ACTIVE COMPARATOR

control group

Drug: placebo

Interventions

metoprololDRUG

using B blocker in patient group

metoprolol
placeboDRUG

placebo to control group

placebo group

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

Related Publications (3)

  • 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.

    PMID: 16865210BACKGROUND

  • Murphy 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.

    PMID: 21055653BACKGROUND

  • Kojury 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.

    PMID: 27326168DERIVED

MeSH Terms

Conditions

beta-Thalassemia

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 18, 2013

First Posted

May 27, 2013

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

December 1, 2012

Last Updated

May 27, 2013

Record last verified: 2013-05

Locations

IR(1)