At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 133 enrolled

Drug / intervention

n-3 PUFAs +1 moredrug

Likely dose

n-3 PUFAs 1.0 gfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01223703

NCT01223703Phase 3Completed

Compare CT.gov

Effects of n-3 Polyunsaturated Fatty Acids (PUFAs) on Left Ventricular Function and Functional Capacity in Patients With Dilated Cardiomyopathy

Università degli Studi di Brescia·interventional·Posted Oct 19, 2010·Updated Jan 31, 2012

In Brief

A Phase 3 clinical trial evaluating n-3 PUFAs and Placebo for Dilated Cardiomyopathy and Heart Failure. Completed, enrolled 133 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDilated Cardiomyopathy, Heart Failure

CountriesItaly

Collaborators--

Timeline

Phase 3CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2007

Primary CompletionJun 2009

First PostedOct 2010

TodayJul 2026

First PostedOct 19, 2010

Enrollment StartNov 1, 2007

Primary CompletionJun 1, 2009

TodayJul 2, 2026

Enrollment to primary: 1.6 yearsPosted 15.7 years ago

Interventions

n-3 PUFAsdrug

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.

Placebodrug

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