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| Name | Class |
|---|---|
| Delta University for Science and Technology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Active Comparator | 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. |
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| Melatonin | Experimental | Participants receive standard heart failure therapy plus melatonin 10 mg orally once daily at bedtime for 3 months. |
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| Selenium | Experimental | Participants receive standard heart failure therapy plus selenium 100 μg orally once daily for 3 months. |
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| Melatonin + Selenium | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 10 MG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular Ejection Fraction (LVEF) | 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. | Baseline and 3 months |
| Change in Left Ventricular End-Diastolic Dimension (LVEDD) | Absolute change in LVEDD measured by echocardiography from baseline to 3 months to evaluate structural remodeling. | Baseline and 3 months |
| Global Longitudinal Strain (GLS) Improvement | Change in GLS (%) assessed by speckle-tracking echocardiography from baseline to 3 months to assess myocardial contractility. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammatory Biomarkers | Absolute changes in serum CRP, IL-6, and TNF-α from baseline to 3 months. These markers assess systemic inflammation and potential anti-inflammatory effects of interventions. | Baseline and 3 months |
| Functional Capacity |
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Inclusion Criteria:
Exclusion Criteria:
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.
Female only, as peripartum cardiomyopathy occurs in women during late pregnancy or postpartum.
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D012643 | Selenium |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Participants are randomly assigned to one of four groups to evaluate effects on left ventricular remodeling and inflammation:
Standard heart failure therapy alone (Control) Standard therapy + Melatonin Standard therapy + Selenium Standard therapy + Melatonin + Selenium
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participants, care providers are blinded.
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| Selenium | Drug | 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. |
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| Placebo | Drug | control group takes Placebo |
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Change in distance walked in the 6-minute walk test (6MWT) from baseline to 3 months to evaluate improvement in exercise tolerance. |
| Baseline and 3 months |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |