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The effect of Ecosapent Ethyl supplementation in heart failure

The effect of Ecosapent Ethyl supplementation on UCP1, PRDM16, CIDEA gene expression, epicardial adipose tissue thickness, and clinical outcomes in overweight and obese patients with heart failure: a randomized, double-blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210427051100N2
Enrollment
50
Registered
2025-04-22
Start date
2025-04-19
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure. Heart failure

Interventions

Intervention 1: Intervention group: EPA received at a dose of 1000 mg twice a day for 12 weeks in the form of soft gel, taken orally, produced by Taka Pharmed. Intervention 2: Control group: 1000 mg o

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age: 30-75 years old EF = 50% with shortness of breath, fatigue, swelling of the extremities, and other symptoms related to heart failure EF =45-50% with one of the following symptoms: shortness of breath, advanced age, atrial fibrillation, or pulmonary disease NYHA Functional class II & III BMI =25 and = 35 Definitive diagnosis of heart failure based on the patient's clinical symptoms and echocardiographic indicators

Exclusion criteria

Exclusion criteria: Participation in another study within the past three months Change in clinical symptoms within the past week Hospitalization and medication changes within the past 1 month due to worsening of the disease Acute illness (cold, corona and any other viral - bacterial - fungal disease) that causes a change in the patient's inflammatory Taking anticoagulant drugs Taking fish oil supplements within the past 1 month Pregnancy and breastfeeding History of cancer, digestive disorders, advanced renal failure (GFR < 30) or liver failure, malignancies, uncontrolled thyroid disorders, immunodeficiency Serious untreated cardiac disorders such as untreated serious arrhythmias, valvular diseases, extensive coronary artery disease History of major surgeries such as CABG, heart attack or stroke, trauma within the past 6 months People who had ACS within the past three months. Use of corticosteroids, chemotherapy drugs Use of drugs that prolong QT including azithromycin and ciprofloxacin and metoclopramide Inability to perform exercise testing or MWT6 Drug and alcohol addiction

Design outcomes

Primary

MeasureTime frame
UCP1. Timepoint: First, before the start of the intervention and at the end of the study. Method of measurement: Real-time PCR.;PRDM16. Timepoint: First, before the start of the intervention and at the end of the study. Method of measurement: Real-time PCR.;CIDEA. Timepoint: First, before the start of the intervention and at the end of the study. Method of measurement: Real-time PCR.

Secondary

MeasureTime frame
Epicardial adipose tissue. Timepoint: At baseline (before the intervention) and at the end of the study. Method of measurement: Echocardiography.;Changes in echocardiographic indicators. Timepoint: At baseline (before the intervention) and at the end of the study. Method of measurement: Echocardiography.;6-minute walk test (6MWT). Timepoint: At baseline (before the intervention) and at the end of the study. Method of measurement: Stopwatch or timer to measure time.;Weight. Timepoint: At baseline (before the intervention) and at the end of the study. Method of measurement: Digital scale.;Waist-to-hip ratio. Timepoint: At baseline (before the intervention) and at the end of the study. Method of measurement: Waist circumference (cm) ÷ Hip circumference (cm).;Systolic blood pressure. Timepoint: At baseline (before the intervention) and at the end of the study. Method of measurement: Blood pressure measuring device.;Heart Failure Quality of Life Questionnaire. Timepoint: At baseline (before the intervention) and at the end of the study. Method of measurement: Questionnaire and scoring.;Body mass index. Timepoint: At baseline (before the intervention) and at the end of the study. Method of measurement: "Body Mass Index (BMI) is calculated as weight (kg) divided by height squared (m²).".

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirhossein hemmati

Tehran University of Medical Sciences

Amirhemati2000@gmail.com88955742

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026