Ppm, Cardiomyopathy
Conditions
Brief 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 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.
Interventions
DRUGMelatonin 10 MG
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.
DRUGSelenium
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.
DRUGPlacebo
control group takes Placebo
Sponsors
Delta University for Science and Technology
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
participants, care providers are blinded.
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Ejection Fraction (LVEF) | 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) | 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 | Baseline and 3 months | Change in GLS (%) assessed by speckle-tracking echocardiography from baseline to 3 months to assess myocardial contractility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inflammatory Biomarkers | Baseline and 3 months | 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. |
| Functional Capacity | Baseline and 3 months | Change in distance walked in the 6-minute walk test (6MWT) from baseline to 3 months to evaluate improvement in exercise tolerance. |
Outcome results
None listed