Cardioprotective Effects of Melatonin in Patients With Cardiomyopathy

NCT06846086 | Recruiting Phase 3

• 1 other identifier: Melatonin cardioprotection
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiomyopathies

Keywords

cardiomyopathy; melatonin

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• composite clinical endpoint score

  baseline , up to 3 month

• Biochemical Markers

  baseline , up to 3 month

Study Arms (2)

Interventional group

EXPERIMENTAL

patients will receive melatonin 10 mg once daily

Drug: Melatonin 10 MG

Control group

PLACEBO COMPARATOR

standard cardiomyopathy therapy for 3 months

Drug: Placebo

Interventions

Melatonin 10 MG DRUG

Melatonin

Interventional group

Placebo DRUG

placebo

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Mansoura University Hospital

Dakahlia, Egypt, Mansoura, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Cardiomyopathies

Interventions

Melatonin

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

Central Study Contacts

Reem Alaa, Bachelor of Pharmacy (2023)

CONTACT

+201124425525; memoalaa19999@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 25, 2025
• Study Start: February 20, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)