Cardioprotective Effects of Melatonin in Patients With Cardiomyopathy (CEMC)

A Clinical Study to Assess the Cardioprotective Effects of Melatonin in Patients With Cardiomyopathy

The aim of current study is to: Evaluate the cardioprotective effects of melatonin in patients with cardiomyopathy.

Study Overview

• Status: Recruiting
• Conditions: Cardiomyopathies
• Intervention / Treatment: Drug: Placebo; Drug: Melatonin 10 MG

Detailed Description

Cardiomyopathy is a progressive and debilitating condition characterized by structural and functional abnormalities of the myocardium, often leading to impaired cardiac function, systemic congestion, and organ dysfunction. It affects millions of individuals worldwide, contributing significantly to morbidity and mortality despite advances in medical management. The pathophysiology of cardiomyopathy is complex and multifactorial, involving neurohormonal activation, oxidative stress, inflammation, and adverse cardiac remodeling. Standard treatments, such as angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, and diuretics, have been shown to improve symptoms and slow disease progression; however, the prognosis remains poor for many patients, emphasizing the urgent need for novel therapeutic strategies.

Melatonin, a neurohormone primarily secreted by the pineal gland, has attracted considerable interest due to its diverse biological properties. Beyond its role in regulating circadian rhythms, melatonin exhibits potent antioxidant and anti-inflammatory effects. It scavenges free radicals, reduces lipid peroxidation, and modulates inflammatory pathways, thereby protecting mitochondrial function and cellular integrity. Experimental studies have demonstrated melatonin's ability to mitigate myocardial injury and improve cardiac function in animal models of cardiomyopathy. Preliminary clinical studies also suggest that melatonin supplementation may improve endothelial function, reduce sympathetic overactivity, and enhance overall cardiovascular health .

Mitochondrial dysfunction is a hallmark of cardiomyopathy. Melatonin has been shown to preserve mitochondrial function by maintaining mitochondrial membrane potential, preventing the opening of the mitochondrial permeability transition pore, and promoting mitophagy-the selective removal of damaged mitochondria. These actions help sustain ATP production and reduce cardiomyocyte apoptosis .

Melatonin's antioxidant capacity extends beyond direct scavenging; melatonin also upregulates the expression of antioxidant enzymes like superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase, while simultaneously inhibiting pro-oxidant enzymes. This dual mechanism makes it particularly effective in mitigating oxidative stress, a key contributor to the pathogenesis of numerous diseases, including cardiovascular disorders, neurodegenerative diseases like Alzheimer's and Parkinson's, diabetes, and cancer. In cardiovascular diseases, melatonin reduces lipid peroxidation and preserves mitochondrial function, protecting against ischemia-reperfusion injury. In neurodegenerative conditions, it minimizes neuronal oxidative damage and supports synaptic integrity. Furthermore, in diabetes, melatonin helps maintain pancreatic β-cell function by countering oxidative stress and inflammation. These multifaceted antioxidant properties make melatonin a promising therapeutic agent in oxidative stress-driven pathologies Given its safety profile and multifaceted mechanisms of action, melatonin holds promise as an adjunctive therapy in managing cardiomyopathy. Its ability to target oxidative stress, inflammation, and mitochondrial dysfunction addresses key pathological processes underlying the disease

In summary, melatonin exhibits several properties that may be beneficial in the context of cardiomyopathy. Ongoing research is essential to fully elucidate its therapeutic potential and to determine optimal dosing strategies for affected patients.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reem Alaa, Bachelor of Pharmacy (2023); Phone Number: +201124425525; Email: memoalaa19999@gmail.com

Study Locations

• Egypt
  • Mansoura
    • Dakahlia, Egypt, Mansoura, Egypt, 35516
      • Recruiting
      • Mansoura University Hospital
      • Contact: Ashraf Mohamed Sewelam, M.B.B.Ch., M.S., M.D.; Phone Number: +2 (050) 2202773; Email: IRB.MFM@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult patients (≥18 years) with a confirmed diagnosis of cardiomyopathy based on clinical, echocardiographic, or imaging findings. .
• Stable condition on standard cardiomyopathy medications (e.g., ACE inhibitors, beta-blockers).
• Ability to provide informed consent.

Exclusion Criteria:

• Recent hospitalization for cardiomyopathy exacerbation (within the last 3 months).
• Severe kidney or liver impairment.
• Use of other investigational drugs or antioxidants.
• Pregnancy or planning to be pregnant in the next 6 months
• Previous known hypersensitivity to melatonin.
• Presence of atrial fibrillation or other significant arrhythmias at baseline.
• Participation in another research.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; patients will receive melatonin 10 mg once daily	Drug: Melatonin 10 MG; Melatonin
Placebo Comparator: Control group; standard cardiomyopathy therapy for 3 months	Drug: Placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Measurement	Unit of Measure: mmHg (Systolic and Diastolic Blood Pressure). • Echocardiography.	baseline , up to 3 month
Heart Rate (HR) Measurement	Unit of Measure: Beats per minute (bpm).	baseline, up to 3 month
Echocardiographic Parameters	Parameters Measured: Left Ventricular Ejection Fraction (LVEF) (%).; Left Ventricular End-Diastolic Diameter (LVEDD) (mm).; Left Ventricular End-Systolic Diameter (LVESD) (mm). GLS %	Baseline , up to 3 months.
Echocardiographic Parameters	Parameters Measured: Left Ventricular Ejection Fraction (LVEF) (%).; Left Ventricular End-Diastolic Diameter (LVEDD) (mm).; Left Ventricular End-Systolic Diameter (LVESD) (mm).	Baseline , up to 3 months.
Serum Concentration of NT Pro- BNP	Changes in serum B-type Natriuretic Peptide (BNP) concentration from baseline to Week 12.	Baseline, up to 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite clinical endpoint score	A composite score incorporating the following parameters: All-cause mortality.; Hospitalization.; Quality of life (QoL) changes, assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ).• Scoring Details:; Scale Name: Kansas City Cardiomyopathy Questionnaire (KCCQ).; Score Range: 0-100.; Interpretation: Higher scores indicate better quality of life and clinical status, while lower scores indicate worse condition.	baseline , up to 3 month
Biochemical Markers	Cardiac biomarkers: Natriuretic peptides (e.g., BNP) for heart stress or damage.; Inflammatory markers: Interleukin-6 (IL-6) which may reflect systemic inflammation.; Antioxidant status: Malondialdehyde (MDA) using commerially available kits.	baseline , up to 3 month

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 22, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: melatonin; cardiomyopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antioxidants; Protective Agents; Melatonin
• Other Study ID Numbers: Melatonin cardioprotection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No