Effect of Melatonin in Peripartum Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Change in Left Ventricular Ejection Fraction (LVEF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
participants, care providers are blinded.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with peripartum cardiomyopathy Age between 18-45 years. Left ventricular ejection fraction (LVEF) ≤ 45% at baseline. Able to provide written informed consent.
排除标准
- •History of pre-existing cardiomyopathy or significant structural heart disease before pregnancy.
- •Severe renal (eGFR <30 mL/min/1.73m²) or hepatic dysfunction. Active infection or inflammatory disease that may confound biomarker measurements.
- •Known hypersensitivity to melatonin or selenium. Current participation in another interventional clinical trial. Inability to comply with study protocol or follow-up visits.
研究组 & 干预措施
control
Participants receive standard guideline-directed heart failure therapy alone. Therapy includes beta-blockers, ACE inhibitors/ARBs/ARNI, diuretics, and mineralocorticoid receptor antagonists as clinically indicated for 3 months.
干预措施: Placebo (Drug)
Melatonin
Participants receive standard heart failure therapy plus melatonin 10 mg orally once daily at bedtime for 3 months.
干预措施: Melatonin 10 MG (Drug)
Selenium
Participants receive standard heart failure therapy plus selenium 100 μg orally once daily for 3 months.
干预措施: Selenium (Drug)
Melatonin + Selenium
Participants receive standard heart failure therapy plus melatonin 10 mg orally once daily at bedtime and selenium 100 μg orally once daily for 3 months.
干预措施: Melatonin 10 MG (Drug)
Melatonin + Selenium
Participants receive standard heart failure therapy plus melatonin 10 mg orally once daily at bedtime and selenium 100 μg orally once daily for 3 months.
干预措施: Selenium (Drug)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction (LVEF)
时间窗: Baseline and 3 months
Absolute change in LVEF measured by transthoracic echocardiography from baseline to 3 months. LVEF will assess left ventricular systolic function and reverse remodeling in participants receiving melatonin, selenium, or combination therapy compared to standard therapy alone.
Change in Left Ventricular End-Diastolic Dimension (LVEDD)
时间窗: Baseline and 3 months
Absolute change in LVEDD measured by echocardiography from baseline to 3 months to evaluate structural remodeling.
Global Longitudinal Strain (GLS) Improvement
时间窗: Baseline and 3 months
Change in GLS (%) assessed by speckle-tracking echocardiography from baseline to 3 months to assess myocardial contractility.
次要结局
- Change in Inflammatory Biomarkers(Baseline and 3 months)
- Functional Capacity(Baseline and 3 months)
研究者
Reem Alaa Abdel Samie
Teacher assistant in faculty of pharmacy, delta university for science and technology
Delta University for Science and Technology