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

Effect of Melatonin in Peripartum Cardiomyopathy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ppm, Cardiomyopathy
• Intervention / Treatment: Drug: Placebo; Drug: Melatonin 10 MG; Drug: Selenium

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Placebo; control group takes Placebo
Experimental: Melatonin; Participants receive standard heart failure therapy plus melatonin 10 mg orally once daily at bedtime for 3 months.	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.; Other Names: melatonin
Experimental: Selenium; Participants receive standard heart failure therapy plus selenium 100 μg orally once daily for 3 months.	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.
Experimental: 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.	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.; Other Names: melatonin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tanta University
• Collaborators: Delta University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2026
• Primary Completion (Estimated): December 20, 2029
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: January 3, 2026
• First Submitted That Met QC Criteria: January 3, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Inorganic Chemicals; Elements; Chalcogens; Minerals; Tryptamines; Melatonin; Selenium
• Other Study ID Numbers: MEL-PPCM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No