NCT07334197

Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy

Effect of Melatonin in Peripartum Cardiomyopathy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Peripartum cardiomyopathy is a rare but serious cause of heart failure in late pregnancy or early postpartum, often associated with significant morbidity. Current treatment primarily relies on guideline-directed heart failure therapy, but adjunctive interventions to accelerate ventricular recovery and mitigate inflammation remain limited. Melatonin, a naturally occurring hormone, has antioxidant, anti-inflammatory, and cardioprotective effects demonstrated in preclinical and clinical heart failure studies. This trial evaluates melatonin as a complementary therapy to improve LV remodeling in PPCM.

Conditions

• Ppm, Cardiomyopathy

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	Placebo	control group takes Placebo

Timeline

• Start date: 2026-12-20
• Primary completion: 2029-12-20
• Completion: 2029-12-30
• First posted: 2026-01-12
• Last updated: 2026-01-12