Using Alpha-Lipoic Acid to Prevent Atrial Fibrillation After Heart Surgery
Effect of Alpha-Lipoic Acid Supplementation on the Incidence of Postoperative Atrial Fibrillation in Cardiac Surgery Patients
This study is testing if taking alpha-lipoic acid can help prevent heart rhythm problems after heart surgery in patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06151652 on ClinicalTrials.gov |
What this trial studies
This study investigates the effect of alpha-lipoic acid (ALA) supplementation on the occurrence of postoperative atrial fibrillation (POAF) in patients undergoing cardiac surgery. ALA, known for its antioxidant and anti-inflammatory properties, will be administered orally to assess its potential in reducing the incidence of POAF, which affects approximately 25% of cardiac surgery patients. The study will involve 350 participants, divided equally between those receiving ALA and a placebo, to evaluate the effectiveness of ALA in preventing this complication. The analysis will utilize statistical methods to determine if ALA significantly lowers the risk of developing POAF compared to the control group.
Who should consider this trial
Good fit: Ideal candidates for this study are male or female patients over 18 years old who are scheduled for elective cardiac surgery.
Not a fit: Patients undergoing urgent or emergency surgeries, or those with significant heart dysfunction or other specified exclusions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment option for patients undergoing cardiac surgery, potentially reducing the incidence of postoperative atrial fibrillation.
How similar studies have performed: Previous studies have indicated potential benefits of alpha-lipoic acid in similar contexts, suggesting this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * I * Male or female patients above 18 years of age who are scheduled for cardiac surgery. Exclusion Criteria: * Any urgent or emergency surgery. * Poor Left ejection volume (EF \< 30%). * Intake of steroids or any antiarrhythmic drugs except beta blockers during the last month before surgery * Unable or unwilling to provide informed written consent. * Pregnancy or lactation * Known hypersensitivity to the study drug. * Current treatment with antioxidants or alpha-lipoic acid for any indication. * Infection or inflammatory disease except coronary artery disease. * Left atrium size \>70 mm.
Where this trial is running
Cairo
- Ain shams university — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: noha tarek mohammed, MSC
- Email: noha.tarek20@pharma.asu.edu.eg
- Phone: 00201007541786
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.