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Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy
Sponsor: Tanta University
Summary
This randomized, controlled clinical trial investigates the potential cardioprotective effects of melatonin in women diagnosed with peripartum cardiomyopathy (PPCM). The study aims to determine whether melatonin supplementation improves left ventricular (LV) function, promotes reverse remodeling, and reduces systemic inflammation. Participants receive standardized heart failure therapy with or without adjunctive melatonin, and outcomes are assessed using echocardiographic parameters (including LVEF, LV dimensions, and global longitudinal strain) and inflammatory biomarkers (e.g., CRP, IL-6, TNF-α). The study hypothesizes that melatonin's antioxidant and anti-inflammatory properties will enhance cardiac recovery, improve functional capacity, and potentially reduce morbidity in PPCM patients.
Official title: Effect of Melatonin in Peripartum Cardiomyopathy
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-12-20
Completion Date
2029-12-30
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
Melatonin 10 MG
Melatonin 10 mg orally once daily at bedtime for 3 months, administered in addition to standard guideline-directed heart failure therapy. Melatonin is a naturally occurring hormone with antioxidant and anti-inflammatory effects, aimed at improving left ventricular reverse remodeling and reducing systemic inflammation in patients with peripartum cardiomyopathy.
Selenium
Selenium 100 μg orally once daily for 3 months, administered in addition to standard guideline-directed heart failure therapy. Selenium is an essential trace element with antioxidant properties, hypothesized to reduce inflammation and improve cardiac recovery in peripartum cardiomyopathy.
Placebo
control group takes Placebo