Ppm, CardiomyopathyMEL-PPCMNCT07334197
Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy
A study testing Melatonin 10 MG and Selenium in people with Ppm, Cardiomyopathy, run by Tanta University.
Trial summary
This randomized, controlled clinical trial investigates the potential cardioprotective effects of melatonin in women diagnosed with peripartum cardiomyopathy (PPCM). The study aims to determine whether melatonin supplementation improves left ventricular (LV) function, promotes reverse remodeling, and reduces systemic… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ppm, Cardiomyopathy
- What is being tested?
- Melatonin 10 MG and Selenium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2026to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with peripartum cardiomyopathy Age between 18-45 years. Left ventricular ejection fraction (LVEF) ≤ 45% at baseline. Able to provide written informed consent.
Who cannot join
- 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.
About this study
Official title: Effect of Melatonin in Peripartum Cardiomyopathy
This randomized, controlled clinical trial investigates the potential cardioprotective effects of melatonin in women diagnosed with peripartum cardiomyopathy (PPCM). The study aims to determine whether melatonin supplementation improves left ventricular (LV) function, promotes reverse remodeling, and reduces systemic inflammation. Participants receive standardized heart failure therapy with or without adjunctive melatonin, and outcomes are assessed using echocardiographic parameters (including LVEF, LV dimensions, and global longitudinal strain) and inflammatory biomarkers (e.g., CRP, IL-6, TNF-α). The study hypothesizes that melatonin's antioxidant and anti-inflammatory properties will enhance cardiac recovery, improve functional capacity, and potentially reduce morbidity in PPCM patients.
Read the detailed description
Peripartum cardiomyopathy is a rare but serious cause of heart failure in late pregnancy or early postpartum, often associated with significant morbidity. Current treatment primarily relies on guideline-directed heart failure therapy, but adjunctive interventions to accelerate ventricular recovery and mitigate inflammation remain limited.
Melatonin, a naturally occurring hormone, has antioxidant, anti-inflammatory, and cardioprotective effects demonstrated in preclinical and clinical heart failure studies. This trial evaluates melatonin as a complementary therapy to improve LV remodeling in PPCM.
- Conditions
- Ppm, Cardiomyopathy
- Being tested
- Melatonin 10 MG, Selenium, Placebo
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 10 MGDrug
Also called melatonin
Melatonin 10 mg orally once daily at bedtime for 3 months, administered in addition to standard guideline-directed heart failure therapy. Melatonin is a naturally occurring hormone with antioxidant and anti-inflammatory effects, aimed at improving left ventricular reverse remodeling and reducing systemic inflammation in patients with peripartum cardiomyopathy.
SeleniumDrug
Selenium 100 μg orally once daily for 3 months, administered in addition to standard guideline-directed heart failure therapy. Selenium is an essential trace element with antioxidant properties, hypothesized to reduce inflammation and improve cardiac recovery in peripartum cardiomyopathy.
PlaceboDrug
control group takes Placebo
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Participants receive standard guideline-directed heart failure therapy alone. Therapy includes beta-blockers, ACE inhibitors/ARBs/ARNI, diuretics, and mineralocorticoid receptor antagonists as clinically indicated for 3 months. Receives: Drug: Placebo |
| Melatonin | Experimental | Participants receive standard heart failure therapy plus melatonin 10 mg orally once daily at bedtime for 3 months. Receives: Drug: Melatonin 10 MG |
| Selenium | Experimental | Participants receive standard heart failure therapy plus selenium 100 μg orally once daily for 3 months. Receives: Drug: Selenium |
| Melatonin + Selenium | Experimental | Participants receive standard heart failure therapy plus melatonin 10 mg orally once daily at bedtime and selenium 100 μg orally once daily for 3 months. Receives: Drug: Melatonin 10 MG; Drug: Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction (LVEF)
Absolute change in LVEF measured by transthoracic echocardiography from baseline to 3 months. LVEF will assess left ventricular systolic function and reverse remodeling in participants receiving melatonin, selenium, or combination therapy compared to standard therapy alone.
Measured: Baseline and 3 months
Change in Left Ventricular End-Diastolic Dimension (LVEDD)
Absolute change in LVEDD measured by echocardiography from baseline to 3 months to evaluate structural remodeling.
Measured: Baseline and 3 months
Global Longitudinal Strain (GLS) Improvement
Change in GLS (%) assessed by speckle-tracking echocardiography from baseline to 3 months to assess myocardial contractility.
Measured: Baseline and 3 months
Secondary outcomes (2)
Change in Inflammatory Biomarkers
Absolute changes in serum CRP, IL-6, and TNF-α from baseline to 3 months. These markers assess systemic inflammation and potential anti-inflammatory effects of interventions.
Measured: Baseline and 3 months
Functional Capacity
Change in distance walked in the 6-minute walk test (6MWT) from baseline to 3 months to evaluate improvement in exercise tolerance.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start20 Dec 2026 (estimated)
- Primary completion20 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ppm, CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of four groups to evaluate effects on left ventricular remodeling and inflammation: Standard heart failure therapy alone (Control) Standard therapy + Melatonin Standard therapy + Selenium Standard therapy + Melatonin + Selenium
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Delta University for Science and Technology
- Responsible party
- Principal investigator, Reem Alaa Abdel Samie, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334197
- Sponsor's protocol ID
- MEL-PPCM
- Acronym
- MEL-PPCM
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin in Peripartum Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07334197
- Acronym / sponsor ID
- MEL-PPCM / MEL-PPCM
- Conditions
- Ppm, Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Delta University for Science and Technology
- Study start
- 20 Dec 2026 (estimated)
- Primary completion
- 20 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 12 Jan 2026 (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.
This randomized, controlled clinical trial investigates the potential cardioprotective effects of melatonin in women diagnosed with peripartum cardiomyopathy (PPCM). The study aims to determine whether melatonin supplementation improves left ventricular (LV) function, promotes reverse remodeling, and reduces systemic inflammation. Participants receive standardized heart failure therapy with or without adjunctive melatonin, and outcomes are assessed using echocardiographic parameters (including LVEF, LV dimensions, and global longitudinal strain) and inflammatory biomarkers (e.g., CRP, IL-6, TNF-α). The study hypothesizes that melatonin's antioxidant and anti-inflammatory properties will enhance cardiac recovery, improve functional capacity, and potentially reduce morbidity in PPCM patients.
Detailed description
Peripartum cardiomyopathy is a rare but serious cause of heart failure in late pregnancy or early postpartum, often associated with significant morbidity. Current treatment primarily relies on guideline-directed heart failure therapy, but adjunctive interventions to accelerate ventricular recovery and mitigate inflammation remain limited.
Melatonin, a naturally occurring hormone, has antioxidant, anti-inflammatory, and cardioprotective effects demonstrated in preclinical and clinical heart failure studies. This trial evaluates melatonin as a complementary therapy to improve LV remodeling in PPCM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Participants are randomly assigned to one of four groups to evaluate effects on left ventricular remodeling and inflammation: Standard heart failure therapy alone (Control) Standard therapy + Melatonin Standard therapy + Selenium Standard therapy + Melatonin + Selenium
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Drug: PlaceboParticipants receive standard guideline-directed heart failure therapy alone. Therapy includes beta-blockers, ACE inhibitors/ARBs/ARNI, diuretics, and mineralocorticoid receptor antagonists as clinically indicated for 3 months. |
| Melatonin | Experimental | Drug: Melatonin 10 MGParticipants receive standard heart failure therapy plus melatonin 10 mg orally once daily at bedtime for 3 months. |
| Selenium | Experimental | Drug: SeleniumParticipants receive standard heart failure therapy plus selenium 100 μg orally once daily for 3 months. |
| Melatonin + Selenium | Experimental | Drug: Melatonin 10 MG, Drug: SeleniumParticipants receive standard heart failure therapy plus melatonin 10 mg orally once daily at bedtime and selenium 100 μg orally once daily for 3 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women diagnosed with peripartum cardiomyopathy Age between 18-45 years. Left ventricular ejection fraction (LVEF) ≤ 45% at baseline. Able to provide written informed consent.
Key exclusion criteria (3 listed)
- 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.
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 MGAlso: melatoninMelatonin 10 mg orally once daily at bedtime for 3 months, administered in addition to standard guideline-directed heart failure therapy. Melatonin is a naturally occurring hormone with antioxidant and anti-inflammatory effects, aimed at improving left ventricular reverse remodeling and reducing systemic inflammation in patients with peripartum cardiomyopathy. | Drug | Melatonin, Melatonin + Selenium |
| SeleniumSelenium 100 μg orally once daily for 3 months, administered in addition to standard guideline-directed heart failure therapy. Selenium is an essential trace element with antioxidant properties, hypothesized to reduce inflammation and improve cardiac recovery in peripartum cardiomyopathy. | Drug | Melatonin + Selenium, Selenium |
| Placebocontrol group takes Placebo | Drug | control |
Primary outcome
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline and 3 months
Absolute change in LVEF measured by transthoracic echocardiography from baseline to 3 months. LVEF will assess left ventricular systolic function and reverse remodeling in participants receiving melatonin, selenium, or combination therapy compared to standard therapy alone.
Change in Left Ventricular End-Diastolic Dimension (LVEDD)
Time frame: Baseline and 3 months
Absolute change in LVEDD measured by echocardiography from baseline to 3 months to evaluate structural remodeling.
Global Longitudinal Strain (GLS) Improvement
Time frame: Baseline and 3 months
Change in GLS (%) assessed by speckle-tracking echocardiography from baseline to 3 months to assess myocardial contractility.
2 secondary outcomes
Change in Inflammatory Biomarkers
Time frame: Baseline and 3 months
Functional Capacity
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 10 MG and Selenium in people with Ppm, Cardiomyopathy, run by Tanta University.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction (LVEF) (time frame: Baseline and 3 months). The study lists 3 primary outcomes in all. 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 12 Jan 2026.