NCT03894683

Brief Summary

The main aim of this study is to investigate the effect of melatonin on clinical outcome, quality of life, and cardiovascular function of the patients with heart failure, as well as its effect on their skeletal muscle mass and function.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

1.4 years

First QC Date

March 27, 2019

Last Update Submit

March 27, 2019

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Heart failureMelatoninMuscle wasting

Outcome Measures

Primary Outcomes (1)

  • Composite clinical endpoint score

    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)

    6 months or earlier if patient was dropped out from the study

Secondary Outcomes (13)

  • Adverse effects of melatonin

    Throughout the study up to 6 months

  • Change in appendicular lean mass (kg)

    Baseline and 6 months

  • Change in lean body mass (kg)

    Baseline and 3 months

  • Change in lean body mass (kg)

    Baseline and 6 months

  • Change in grip strength (kg)

    Baseline and 3 months

  • +8 more secondary outcomes

Other Outcomes (7)

  • Change in fasting blood glucose level (mg/dl)

    Baseline and 6 months

  • Change in serum lipid levels (mg/dl)

    Baseline and 6 months

  • Change in serum insulin, and IGF-1 levels

    Baseline and 6 months

  • +4 more other outcomes

Study Arms (2)

Melatonin

EXPERIMENTAL

Melatonin (10 mg tablets) by oral root, ingested at bedtime for 6 months

Drug: Melatonin 10 mg

Placebo

PLACEBO COMPARATOR

Placebo tablets in the same shape as melatonin tablets, ingested the same as the melatonin tablets.

Drug: Placebo Oral Tablet

Interventions

Melatonin 10 mgDRUG

Melatonin tablets (10 mg)

Melatonin
Placebo Oral TabletDRUG

Placebo tablets manufactured the same as melatonin tablets

Placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systolic heart failure with ejection fraction \< 40, either ischemic or dilated cardiomyopathy (DCM)
  • Symptoms and medications of HF have been stable for at least three months
  • NYHA class II-III
  • Willing to participate in the study and providing informed consent

You may not qualify if:

  • Chronic comorbidities: insulin dependent diabetes, renal failure (GFR \< 30 mL/min per 1.73 m2), uncontrolled endocrine disease, end-stage liver disease, rheumatological disease, chronic obstructive pulmonary disease (class D according to GOLD classification), morbid obesity (BMI \> 35)
  • Acute ischemic heart event or revascularization procedure in the last month
  • Regular supervised exercise or ingestion of muscle hypertrophy supplementations in the last three months
  • Vegetarian diet or sever restriction of protein in the diet in the last three months
  • Occurrence of melatonin related adverse effects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac rehabilitation research center

Isfahan, Iran

RECRUITING

MeSH Terms

Conditions

Heart FailureMuscular Atrophy

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Masoumeh Sadeghi, MD

    Cardiac Rehabilitation Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shervin Gh Hoseini, MD, PhD

CONTACT

00989131081854shghaffari@yahoo.com

Masoumeh Sadeghi, MD

CONTACT

00983136115208sadeghimasoumeh@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiac Rehabilitation Research Center

Study Record Dates

First Submitted

March 27, 2019

First Posted

March 28, 2019

Study Start

November 30, 2018

Primary Completion

May 1, 2020

Study Completion

December 1, 2020

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Six months after publication

Locations

IR(1)