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PUFAs and Left Ventricular Function in Heart Failure

NCT01223703 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2012-01-31

Study results available
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Summary

The purpose of this study is to test the hypothesis that n-3 PUFAs improve left ventricular systolic function in patients with stable chronic HF secondary to nonischemic dilated cardiomyopathy (NICM).

Conditions

Interventions

DRUG

n-3 PUFAs

1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.

DRUG

Placebo

1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study

Sponsors & Collaborators

  • Università degli Studi di Brescia

    lead OTHER

Principal Investigators

  • Savina Nodari, MD · Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases

  • Livio Dei Cas, MD · Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01223703 on ClinicalTrials.gov