Not Yet RecruitingNot Applicable

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

25 participantsStarted 2026-12-20

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Left Ventricular Ejection Fraction (LVEF)

Timeframe: Baseline and 3 months

Change in Left Ventricular End-Diastolic Dimension (LVEDD)

Timeframe: Baseline and 3 months

Global Longitudinal Strain (GLS) Improvement

Timeframe: Baseline and 3 months

Trial details

NCT IDNCT07334197

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-20

View on ClinicalTrials.gov More Ppm, Cardiomyopathy trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.