Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 20 of 21

List	Outcome	Time frame	Description
Primary	Composite clinical endpoint score	6 months or earlier if patient was dropped out from the study	A score with the following components: all-cause mortality, hospitalization for heart failure during the study, and change in quality of life by Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Secondary	Adverse effects of melatonin	Throughout the study up to 6 months	Adverse effects detected in the melatonin group compared with the placebo group
Secondary	Change in appendicular lean mass (kg)	Baseline and 6 months	Measured by dual-energy x-ray absorptiometry
Secondary	Change in lean body mass (kg)	Baseline and 3 months	Measured by bioimpedance analysis
Secondary	Change in lean body mass (kg)	Baseline and 6 months	Measured by bioimpedance analysis
Secondary	Change in grip strength (kg)	Baseline and 3 months	Measured by a hydraulic dynamometer
Secondary	Change in grip strength (kg)	Baseline and 6 months	Measured by a hydraulic dynamometer
Secondary	Change in exercise capacity	Baseline and 3 months	Measured by 6 minute walk test
Secondary	Change in exercise capacity	Baseline and 6 months	Measured by 6 minute walk test
Secondary	Change in Left ventricular ejection fraction (LVEF)	Baseline and 6 months	Measured by echocardiography using the Simpson method
Secondary	Change in left ventricular end-systolic volume (LVESV)	Baseline and 6 months	Measured by echocardiography using the Simpson method
Secondary	Change in endothelial dysfunction	Baseline and 6 months	Measured by flow-mediated vasodilation (FMD) method
Secondary	Change in mean systolic and diastolic blood pressures	Baseline and 3 months	Mean of two measurements, using an automated electronic oscillometric device
Secondary	Change in mean systolic and diastolic blood pressures	Baseline and 6 months	Mean of two measurements, using an automated electronic oscillometric device
Other	Change in fasting blood glucose level (mg/dl)	Baseline and 6 months	Measured in serum samples after 12h fasting
Other	Change in serum lipid levels (mg/dl)	Baseline and 6 months	Including triglyceride, LDL, and HDL, measured in serum samples after 12h fasting
Other	Change in serum insulin, and IGF-1 levels	Baseline and 6 months	Measured by enzyme-linked immunosorbent assay (ELISA) on serum samples stored at -80°
Other	Change in level of serum inflammatory biomarkers	Baseline and 6 months	Measured by enzyme-linked immunosorbent assay (ELISA) on serum samples stored at -80°
Other	Change in level of serum oxidative stress biomarkers	Baseline and 6 months	Including malondialdehyde (MDA) and total antioxidant capacity (TAC)
Other	Changes in psychological status of the patients	Baseline and 6 months	Including anxiety (by Spielberger State - Trait Anxiety Inventory (STAI)) and depression (by Beck Depression Inventory)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Registered outcomes21

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