NCT01223703

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 25, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

1.6 years

First QC Date

October 18, 2010

Results QC Date

April 11, 2011

Last Update Submit

January 27, 2012

Conditions

Dilated CardiomyopathyHeart Failure

Keywords

n-3 PUFAsHeart FailureDilated cardiomyopathyEjection FractionExercise Capacity

Outcome Measures

Primary Outcomes (1)

  • Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up

    The primary end point of the study was the change in LV systolic function expressed as LVEF between baseline and 12-month follow-up. The following parameters were measured according to the professional standards defined by the American Society of Echocardiography and the European Association of Echocardiography

    one year

Secondary Outcomes (3)

  • LV Diastolic Function

    one year

  • Functional Capacity (Change in Peak Oxygen Uptake, VO2)

    one year

  • Change in Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up.

    one year

Study Arms (2)

n-3 PUFAs

ACTIVE COMPARATOR
Drug: n-3 PUFAs

Placebo

PLACEBO COMPARATOR
Drug: Placebo

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.

Also known as: OMACOR, Pronova Biopharma, Lysaker, Norway
n-3 PUFAs
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

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with a diagnosis of non ischemic cardiomyopathy (the absence of coronary artery disease,defined as the absence of stenosis \> 50%, was confirmed by angiography performed at the time of the diagnostic workup of the cardiomyopathy)
  • LV systolic dysfunction (defined as an EF \< 45%)
  • Stable clinical conditions with minimal or no symptoms for at least three month
  • Evidence-based medical treatment at maximum tolerated target doses for at least six month

You may not qualify if:

  • presence of symptoms or evidence of CAD diagnosed through noninvasive tests;
  • peripheral arterial disease;
  • presence of congenital or primary valvular heart disease;
  • persistent atrial fibrillation;
  • inability to perform bicycle ergometry for noncardiac causes;
  • moderately to severely reduced functional capacity;
  • NYHA functional class IV;
  • poor acoustic windows limiting the ability to assess echocardiographic measurements;
  • chronic lung disease;
  • advanced renal disease (eGFR \< 30 mL/min/1.73 m2);
  • advanced liver disease;
  • any disease limiting life expectancy to one year or less;
  • contraindications to study drugs;
  • concomitant participation in other research studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arrhytmias and Heart failure Unit-Spedali Civili Hospital

Brescia, 25100, Italy

Location

Related Publications (1)

  • 1.Tavazzi L, Maggioni AP, Marchioli R, et al. Effect of n-3polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet2008;372:1223-30. 2.Duda MK, O'Shea KM, Tintinu A, et al. Fish oil, but not flaxseed oil, decreases inflammation and prevents pressure overload-induced cardiac dysfunction. Cardiovasc Res 2009;81:319-27. 3.Duda MK, O'Shea KM, Lei B, et al. Dietary supplementation with omega-3 PUFA increases adiponectin and attenuates ventricular remodeling and dysfunction with pressure overload. Cardiovasc Res 2007;76:303-10. 4.Vargiu R, Littarru GP, Fraschini M, et al. Enhancement of shortening velocity, power, and acto-myosin crossbridge (CB) kinetics following long-term treatment with propionyl-L-carnitine, coenzyme Q10, and omega-3 fatty acids in BIO TO-2 cardiomyopathic Syrian hamsters papillary muscle. Biofactors 2010;36:229-39. 5.Pepe S, McLennan PL. Cardiac membrane fatty acid composition modulates myocardial oxygen consumption and postischemic recovery of contractile function. Circulation 2002;105:2303-8. 6.Duda MK, O'Shea KM, Stanley WC. omega-3 polyunsaturated fatty acid supplementation for the treatment of heart failure: mechanisms and clinical potential. Cardiovasc Res 2009;84:33-41.

    BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, DilatedHeart Failure

Interventions

Omacor

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Our investigation was a single-center trial with a small sample size and a limited number of clinical events. Therefore, our results cannot be generalized to HF patients.

Results Point of Contact

Title
Dr Savina Nodari
Organization
Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
nodari@med.unibs.it
00390303996

Study Officials

  • Savina Nodari, MD

    Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR

  • Livio Dei Cas, MD

    Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effects of n-3 Polyunsaturated Fatty Acids (PUFAs) on Left Ventricular Function and Functional Capacity in Patients With Dilated Cardiomyopathy

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 19, 2010

Study Start

November 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 31, 2012

Results First Posted

July 25, 2011

Record last verified: 2012-01

Locations

IT(1)