Heart Failure With Reduced Ejection FractionPhase 2NCT03894683
Effect of Melatonin on Cardiovascular and Muscle Mass and Function in Patients With Heart Failure
A Phase 2 study testing Melatonin 10 mg in people with Heart Failure With Reduced Ejection Fraction, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Melatonin 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- 30 Nov 2018to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Cardiac rehabilitation research center
Isfahan
masoumeh sadeghi, M.D., sadeghimasoumeh@gmail.com
About this study
Official title: Effect of Melatonin on Cardiovascular and Muscle Function in Patients With Heart Failure: a Double Blinded Prospective Randomized Clinical Trial.
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.
Read the detailed description
People with heart failure (HF) suffer from various comorbidities and complications which their management is as important as treatment of HF per se. An important complication of the HF is progressive decrease in muscle mass and function known as muscle wasting or sarcopenia. Prevention, diagnosis, and treatment of muscle wasting is emphasized to improve prognosis and quality of life of the patients with HF. Melatonin is a natural hormone which is secreted from pineal gland and is involved in circadian rhythm control. Recent data delineates more important roles for melatonin in cellular metabolism and apoptosis, as well as acting as an antioxidant and anti-inflammatory agent in the body. Experimental studies show that melatonin can have a beneficial role in muscle wasting in several chronic conditions such as heart failure. Furthermore melatonin has been shown to have valuable effects on cardiovascular health, blood pressure, and endothelial function and it might benefit patients with heart failure. In this study the effect of melatonin on clinical outcome and quality of life of the patients with HF and their echocardiographic parameters, muscle mass, muscle function, inflammatory biomarkers, serum metabolic parameters, and serum oxidative stress markers will be studied.
- Being tested
- Melatonin 10 mg, Placebo Oral Tablet
- Keywords
- Heart failure, Melatonin, Muscle wasting
- Medical subject headings
- Heart Failure, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 10 mgDrug
Melatonin tablets (10 mg)
Placebo Oral TabletDrug
Placebo tablets manufactured the same as melatonin tablets
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Melatonin (10 mg tablets) by oral root, ingested at bedtime for 6 months Receives: Drug: Melatonin 10 mg |
| Placebo | Placebo comparator | Placebo tablets in the same shape as melatonin tablets, ingested the same as the melatonin tablets. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months or earlier if patient was dropped out from the study
Secondary outcomes (13)
Adverse effects of melatonin
Adverse effects detected in the melatonin group compared with the placebo group
Measured: Throughout the study up to 6 months
Change in appendicular lean mass (kg)
Measured by dual-energy x-ray absorptiometry
Measured: Baseline and 6 months
Change in lean body mass (kg)
Measured by bioimpedance analysis
Measured: Baseline and 3 months
Change in lean body mass (kg)
Measured by bioimpedance analysis
Measured: Baseline and 6 months
Change in grip strength (kg)
Measured by a hydraulic dynamometer
Measured: Baseline and 3 months
Change in grip strength (kg)
Measured by a hydraulic dynamometer
Measured: Baseline and 6 months
Change in exercise capacity
Measured by 6 minute walk test
Measured: Baseline and 3 months
Change in exercise capacity
Measured by 6 minute walk test
Measured: Baseline and 6 months
Change in Left ventricular ejection fraction (LVEF)
Measured by echocardiography using the Simpson method
Measured: Baseline and 6 months
Change in left ventricular end-systolic volume (LVESV)
Measured by echocardiography using the Simpson method
Measured: Baseline and 6 months
Change in endothelial dysfunction
Measured by flow-mediated vasodilation (FMD) method
Measured: Baseline and 6 months
Change in mean systolic and diastolic blood pressures
Mean of two measurements, using an automated electronic oscillometric device
Measured: Baseline and 3 months
Change in mean systolic and diastolic blood pressures
Mean of two measurements, using an automated electronic oscillometric device
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start30 Nov 2018
- Primary completionMay 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research and Development
- Responsible party
- Principal investigator, Masoumeh Sadeghi, Isfahan University of Medical Sciences
- Investigators
- Masoumeh Sadeghi, MD, Principal investigator, Cardiac Rehabilitation Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894683
- Sponsor's protocol ID
- 397180
- Status last verified
- Mar 2019
- First submitted
- 27 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin on Cardiovascular and Muscle Function in Patients With Heart Failure: a Double Blinded Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03894683
- Acronym / sponsor ID
- 397180
- Keywords
- Heart failure, Melatonin, Muscle wasting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Collaborators
- National Institute for Medical Research and Development
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
People with heart failure (HF) suffer from various comorbidities and complications which their management is as important as treatment of HF per se. An important complication of the HF is progressive decrease in muscle mass and function known as muscle wasting or sarcopenia. Prevention, diagnosis, and treatment of muscle wasting is emphasized to improve prognosis and quality of life of the patients with HF. Melatonin is a natural hormone which is secreted from pineal gland and is involved in circadian rhythm control. Recent data delineates more important roles for melatonin in cellular metabolism and apoptosis, as well as acting as an antioxidant and anti-inflammatory agent in the body. Experimental studies show that melatonin can have a beneficial role in muscle wasting in several chronic conditions such as heart failure. Furthermore melatonin has been shown to have valuable effects on cardiovascular health, blood pressure, and endothelial function and it might benefit patients with heart failure. In this study the effect of melatonin on clinical outcome and quality of life of the patients with HF and their echocardiographic parameters, muscle mass, muscle function, inflammatory biomarkers, serum metabolic parameters, and serum oxidative stress markers will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: Melatonin 10 mgMelatonin (10 mg tablets) by oral root, ingested at bedtime for 6 months |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo tablets in the same shape as melatonin tablets, ingested the same as the melatonin tablets. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 10 mgMelatonin tablets (10 mg) | Drug | Melatonin |
| Placebo Oral TabletPlacebo tablets manufactured the same as melatonin tablets | Drug | Placebo |
Primary outcome
Composite clinical endpoint score
Time frame: 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)
13 secondary outcomes
Adverse effects of melatonin
Time frame: Throughout the study up to 6 months
Change in appendicular lean mass (kg)
Time frame: Baseline and 6 months
Change in lean body mass (kg)
Time frame: Baseline and 3 months
Change in lean body mass (kg)
Time frame: Baseline and 6 months
Change in grip strength (kg)
Time frame: Baseline and 3 months
Change in grip strength (kg)
Time frame: Baseline and 6 months
Change in exercise capacity
Time frame: Baseline and 3 months
Change in exercise capacity
Time frame: Baseline and 6 months
Change in Left ventricular ejection fraction (LVEF)
Time frame: Baseline and 6 months
Change in left ventricular end-systolic volume (LVESV)
Time frame: Baseline and 6 months
Change in endothelial dysfunction
Time frame: Baseline and 6 months
Change in mean systolic and diastolic blood pressures
Time frame: Baseline and 3 months
Change in mean systolic and diastolic blood pressures
Time frame: Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masoumeh Sadeghi, MD principal investigator
Cardiac Rehabilitation Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin 10 mg in people with Heart Failure With Reduced Ejection Fraction, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shervin Gh Hoseini, MD, PhD (00989131081854, shghaffari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite clinical endpoint score (time frame: 6 months or earlier if patient was dropped out from the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.