Atrial Fibrillation (AF)
Conditions
Brief summary
The aim of this clinical study is to evaluate the efficacy and tolerability of probiotics on atrial fibrillation recurrence.
Detailed description
Assessment of AF recurrence: Early AF recurrence is defined as relapse into AF within 1 week following successful cardioversion and AF recurrence through the study's 12-week follow-up. Patients and Methods Design: Prospective, randomized, open label, controlled clinical trial Patients: A total of 56 AF patients undergoing cardioversion will be randomly enrolled into one of 2 arms: 1. Group 1 (Control group) (n=28): AF patients undergoing cardioversion who will receive the standard of care 2. Group 2 (Probiotic group) (n = 28): AF patients undergoing cardioversion who will receive the standard of care in addition to probiotics DAILY orally administered (Probiotics 25 billion) after cardioversion for 12 weeks. Groups (1 & 2) will be subjected to cardioversion on admission according to standard protocols and criteria.
Interventions
DRUGAnticoagulant Therapy
Drug: The standard of care for AF management directly following cardioversion Include anticoagulant therapy for at least 4 weeks, rate control therapy, rhythm control therapy, or both as per clinical and guideline decisions.
DRUGProbiotics capsules
Probiotics at a of dose 25 billion / 1 capsule will be orally administered daily for 12 weeks
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female or male aged 40 years or above with BMI less than 40 2. Persistent AF patients directly after cardioversion
Exclusion criteria
1. History of probiotic supplementation in the previous 6 weeks 2. Autoimmune diseases 3. Ongoing treatment with immunosuppressive therapies 4. Active Infection 5. Pregnant or breast-feeding patients 6. Active participation in another clinical study 7. History of or known allergy or intolerability to the study medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial Fibrillation Recurrence | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Atrial Fibrillation Recurrence | 12 weeks |
Countries
Egypt
Contacts
CONTACTSarah M. Raesah
Outcome results
None listed