Status:

COMPLETED

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

Lead Sponsor:

Mazandaran University of Medical Sciences

Conditions:

Pulmonary Artery Pressure

Thalassemia

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

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 ans...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

August 15 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 27 2025

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT07210450

Start Date

August 15 2023

End Date

September 27 2025

Last Update

October 7 2025

Active Locations (1)

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1

Bu'Ali Sina Hospital

Sari, Mazandaran, Iran, 4815738477