PUFAs and Left Ventricular Function in Heart Failure

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Brief Title

PUFAs and Left Ventricular Function in Heart Failure

Official Title

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

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).
    

Detailed Description

      The results of the GISSI-HF trial indicate that in patients with chronic HF on evidence-based
      medical therapy and New York Heart Association (NYHA) functional class II-IV, long term
      treatment with n-3 PUFAs 1 g daily reduces mortality and hospitalizations for cardiovascular
      reasons. Several potential mechanisms may underlie the beneficial effects of n-3
      polyunsaturated fatty acids (PUFAs) in HF patients, including, but not limited to,
      antiarrhythmic, and hemodynamic actions. The current investigation was therefore designed to
      test the hypothesis that treatment with n-3 PUFAs improves LV systolic function expressed as
      EF in patients with stable chronic HF secondary to a nonischemic dilated cardiomyopathy
      (NICM). Additionally, we sought to determine if n-3 PUFAs also exert positive effects on LV
      diastolic function assessed by echocardiography; functional capacity assessed by
      cardiopulmonary stress testing (CPET); and New York Heart Association (NYHA) functional
      class.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 LV Diastolic Function

Condition

Dilated Cardiomyopathy

Intervention

n-3 PUFAs

Study Arms / Comparison Groups

 n-3 PUFAs
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

133

Start Date

November 2007

Completion Date

June 2009

Primary Completion Date

June 2009

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Savina Nodari, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT01223703

Organization ID

CS-PUFA-02


Responsible Party

Principal Investigator

Study Sponsor

Università degli Studi di Brescia


Study Sponsor

Savina Nodari, MD, Principal Investigator, Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases


Verification Date

January 2012