CompletedPhase 2/3

Effect of L-Glutamine on Pulmonary Artery Pressure in Patients With Non-Transfusion-Dependent Thalassemia

Iran8 participantsStarted 2023-08-15

Plain-language summary

The goal of this clinical trial is to learn whether L-glutamine can help lower pulmonary artery pressure in adults with non-transfusion-dependent thalassemia (NTDT). The main questions it aims to answer are: Does L-glutamine reduce pulmonary artery pressure after 60 days of treatment? Is the effect of L-glutamine different from standard care alone? Researchers will compare two groups: Intervention group: Participants receive oral L-glutamine in addition to their standard treatment. Control group: Participants continue with standard treatment only. Participants will: Take either L-glutamine (by mouth) or standard care for 60 days. Undergo echocardiography at the beginning and end of the study to measure pulmonary artery pressure. Attend follow-up visits to monitor safety, adherence, and possible side effects.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults (≥18 years), any sex. * Diagnosis of non-transfusion-dependent β-thalassemia (NTDT). * Pulmonary artery pressure (PAP) \> 35 mmHg estimated by Doppler echocardiography at screening. * Able and willing to provide written informed consent. * On a stable standard-of-care regimen (e.g., chelation and/or hydroxyurea) per treating physician judgment. Exclusion Criteria: * Age \<18 years. * Refusal or inability to provide informed consent. * Hepatic dysfunction: ALT \>3× upper limit of normal. * Renal dysfunction: serum creatinine \>2× upper limit of normal. * Known hypersensitivity to L-glutamine. * Pregnancy or breastfeeding. * Use of amino-acid/protein supplements within the past 3 months. * History of other cardiac diseases associated with pulmonary hypertension (per investigator assessment).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pulmonary Artery Pressure (PAP)

Timeframe: Baseline to 60 days

Trial details

NCT IDNCT07210450

SponsorMazandaran University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-22

View on ClinicalTrials.gov More Pulmonary Artery Pressure trials