Effects of N-acetylcysteine on cardiovascular parameters in thalassemia major patients

Phase 4

Recruiting

• Conditions: N- Magnetic resonance acquisition; Thalassemia major; HRV parameters; acetylcysteine (NAC) therapy

• Registration Number: TCTR20160725002
• Lead Sponsor: The Faculty of Medicine Endowment fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-25
• Study Completion: 2016-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All diagnosed thalassemia major patients aged 18 years or older currently treated with regular blood transfusion and iron chelation therapy

Exclusion Criteria

Patients will be excluded if they have apparent heart diseases, diabetes mellitus, atrial flutter, atrial fibrillation, thyrotoxicosis, pacemaker installation, or had been taking any
medications, which affected autonomic function including contraceptive, tricyclic antidepressant, anticholinergic agents, amphotericin B, calcium channel blocker, beta-blocker, antiarrhythmic, and centrally acting antihypertensive agents.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of HRV after NAC therapy compared to placebo 12 months Holter monitor

Secondary Outcome Measures

Name	Time	Method
The change of myocardial iron after NAC therapy compared to placebo 12 months Magnetic resonance acquisition,The change of left ventricular function after NAC therapy compared to placebo 12 months Echocadiogram,The change of oxidative stress and inflammatory markers after NAC therapy compared to placebo 12 months Blood collection for inflammatory markers and oxidative stress test