Could a sleep hormone help heal damaged hearts in new moms?
NCT ID NCT07334197
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding melatonin (a natural sleep hormone) to standard heart failure treatment can improve heart function in women with peripartum cardiomyopathy, a rare heart condition that develops during or after pregnancy. 25 women will receive either melatonin, selenium, or a placebo for 3 months. The goal is to see if these supplements help the heart pump better and reduce inflammation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Melatonin (10 mg daily) and Selenium (100 mcg daily)
- What this could lead to
- If it works, this could point toward a simple, low-cost addition to standard heart failure therapy for women with peripartum cardiomyopathy, potentially improving heart recovery.
- What could go wrong
- This is a very small, early-phase trial with only 25 participants. The results may not apply to all patients, and the benefits of melatonin for heart function are not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women diagnosed with peripartum cardiomyopathy Age between 18-45 years. Left ventricular ejection fraction (LVEF) ≤ 45% at baseline. Able to provide written informed consent. Exclusion Criteria: * History of pre-existing cardiomyopathy or significant structural heart disease before pregnancy. Severe renal (eGFR \<30 mL/min/1.73m²) or hepatic dysfunction. Active infection or inflammatory disease that may confound biomarker measurements. Known hypersensitivity to melatonin or selenium. Current participation in another interventional clinical trial. Inability to comply with study protocol or follow-up visits.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.