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

Not Applicable

Completed

• Conditions: Pulmonary Artery Pressure; Thalassemia; Non-transfusion Dependent Thalassemia
• Interventions: Drug: L-glutamine

• Registration Number: NCT07210450
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-15
• Primary Completion: 2025-05-22
• Status Verified: 2025-09
• Study Completion: 2025-09-27
• Study First Submitted: 2025-09-29
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-Glutamine + Standard Care	L-glutamine	Participants in this arm will receive oral L-glutamine at a dose of 0.1 g/kg/day for 60 days, in addition to their routine standard care for non-transfusion-dependent thalassemia

Primary Outcome Measures

Name	Time	Method
Change in Pulmonary Artery Pressure (PAP)	Baseline to 60 days	Pulmonary artery pressure (PAP) will be measured by Doppler echocardiography at baseline and at 60 days. The primary endpoint is the change in PAP (ΔPAP = Follow-up PAP - Baseline PAP) to assess whether L-glutamine reduces pulmonary artery pressure compared with standard care alone.

Secondary Outcome Measures

Name	Time	Method
Clinical Response Rate	60 days	Proportion of participants achieving either an absolute reduction in PAP ≥10 mmHg or a relative reduction ≥20% from baseline.
Safety and Tolerability of L-Glutamine	Baseline to 60 days	Monitoring of adherence, adverse events, and treatment discontinuations related to L-glutamine supplementation.
Iron Load	Baseline to 60 days	Association between change in pulmonary artery pressure (ΔPAP) and iron overload indices (Cardiac T2\*, Liver T2\*, and Liver Iron Concentration).

Trial Locations

Locations (1)

Bu'Ali Sina Hospital; 🇮🇷 Sari, Mazandaran, Iran