Evidence map›Paper›PMID 31413542›Full record

Trial reportDrug design, development and therapy2019

A randomized controlled trial evaluating the effects of amlodipine on myocardial iron deposition in pediatric patients with thalassemia major.

Arwa Khaled, Hoda A Salem, Dina A Ezzat, Hadeel M Seif, Hoda Rabee

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Iron overload cardiomyopathy.Heart failure reviews · 2026
    Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Regulated cell death pathways in cardiomyopathy.Acta pharmacologica Sinica · 2023
    Review
  9. Article
  10. Review
  11. The Role of Iron in Benign and Malignant Hematopoiesis.Antioxidants & redox signaling · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Arwa KhaledDepartment of Clinical Pharmacy, Beni-Suef University Hospital, Beni-Suef University, Beni Suef, 62515, Egypt.
Hoda A SalemDepartment of Clinical Pharmacy, Faculty of Pharmacy, Al-azhar University, Girl Branch, Cairo, 12655, Egypt.
Dina A EzzatDepartment of Pediatrics and Pediatric Hematology, Faculty of Medicine, Beni-Suef University, Beni Suef, 12568, Egypt.
Hadeel M SeifDepartment of Radiology, Faculty of Medicine, Cairo University Cairo, Cairo 8582, Egypt.
Hoda RabeeDepartment of Clinical Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, 62514, Egypt.
Beni-Suef University · EGAl-Azhar University · EGCairo University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMortality rates increase due to iron deposition in the cardiac muscles of thalassemia major (TM) patients. Iron overload cardiomyopathy could be treated with a combination therapy of an iron chelator and an L-type calcium channel blocker. We designed a randomized controlled study to assess the potential of amlodipine, alongside chelation, in reducing myocardial iron concentration in TM patients compared with a placebo.

objectivesThis study aims to estimate the change in myocardial iron concentration (MIC) determined by magnetic resonance imaging after 6 months of treatment with amlodipine, as well as measuring the changes in the secondary outcomes (liver iron concentration (LIC), serum ferritin level (SF), and left ventricle ejection fraction (LVEF)) of study participants.

methodsA single, randomized, placebo-controlled trial was performed in 40 β-Thalassemia major patients aged between 6 and 20 years old, who received either oral amlodipine 2.5-5 mg/day or a placebo, in addition to a Deferasirox chelation regimen in a 1:1 allocation ratio.

resultsAfter 6 months, a significant reduction was noted in the MIC of patients receiving amlodipine (n=20), compared with the patients receiving the placebo (n=20). At baseline, the mean was 0.76±0.11 mg/g dry weight, while at 6 months, the mean was 0.51±0.07 mg/g dry weight (

conclusionThe addition of amlodipine to the standard chelation therapy in transfusion-dependent thalassemia major patients improves myocardial iron overload without increasing the adverse effects.

Indexed as

AdolescentAdultAmlodipinebeta-ThalassemiaCalcium Channel BlockersChildFemaleHumansIronIron Chelating AgentsIron OverloadMagnetic Resonance ImagingMaleProspective StudiesYoung AdultAmlodipineCalcium Channel BlockersIronIron Chelating Agentsamlodipinemagnetic resonance imagingmyocardial iron concentrationthalassemia major

Identifiers

PMID31413542
PMCPMC6659783
OpenAlexW2964226851

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.