Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy (MEL-PPCM)

Tanta University

Status: Begins enrollment in 10 months

Conditions: Ppm, Cardiomyopathy

Treatments: Drug: Placebo; Drug: Selenium; Drug: Melatonin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT07334197

MEL-PPCM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women diagnosed with peripartum cardiomyopathy Age between 18-45 years. Left ventricular ejection fraction (LVEF) ≤ 45% at baseline. Able to provide written informed consent.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 4 patient groups

control

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Melatonin

Experimental group

Description:

Participants receive standard heart failure therapy plus melatonin 10 mg orally once daily at bedtime for 3 months.

Treatment:

Drug: Melatonin 10 MG

Selenium

Experimental group

Description:

Participants receive standard heart failure therapy plus selenium 100 μg orally once daily for 3 months.

Treatment:

Drug: Selenium

Melatonin + Selenium

Experimental group

Description:

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.

Treatment:

Drug: Selenium

Drug: Melatonin 10 MG