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

NCT07334197 | Not Yet Recruiting DMC

• 1 other identifier: MEL-PPCM
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ppm, Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in Inflammatory Biomarkers

  Baseline and 3 months

• Functional Capacity

  Baseline and 3 months

Study Arms (4)

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.

Drug: Placebo

Melatonin

EXPERIMENTAL

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

Drug: Melatonin 10 MG

Selenium

EXPERIMENTAL

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

Drug: Selenium

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.

Drug: Melatonin 10 MG; Drug: Selenium

Interventions

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.

Also known as: melatonin

Melatonin; Melatonin + Selenium

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.

Melatonin + Selenium; Selenium

Placebo DRUG

control group takes Placebo

control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female only, as peripartum cardiomyopathy occurs in women during late pregnancy or postpartum.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead
• Delta University for Science and Technology: collaborator

MeSH Terms

Conditions

Cardiomyopathies

Interventions

Melatonin; Selenium

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: participants, care providers are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher assistant in faculty of pharmacy, delta university for science and technology

Model Details: 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

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 12, 2026
• Study Start (Estimated): December 20, 2026
• Primary Completion (Estimated): December 20, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01