PUFAs and Left Ventricular Function in Heart Failure (CS-PUFA-02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Savina Nodari, Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT01223703
First received: October 18, 2010
Last updated: January 27, 2012
Last verified: January 2012

October 18, 2010
January 27, 2012
November 2007
June 2009   (final data collection date for primary outcome measure)
Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up [ Time Frame: one year ] [ Designated as safety issue: No ]
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
Improvement in left ventricular systolic function [ Time Frame: one year ] [ Designated as safety issue: No ]
The primary end point of the study was the improvement in left ventricular systolic function expressed as left ventricular ejection fraction by echocardiography.
Complete list of historical versions of study NCT01223703 on ClinicalTrials.gov Archive Site
  • LV Diastolic Function [ Time Frame: one year ] [ Designated as safety issue: No ]
    Change in LV diastolic function assessed by echocardiography: mitral diastolic inflow velocities (peak velocity of early ventricular filling [E-wave], peak velocity of late ventricular filling [A-wave], E/A ratio, and E-wave deceleration time), diastolic function score (graded on a scale from 1 to 4) were used.
  • Functional Capacity (Change in Peak Oxygen Uptake, VO2) [ Time Frame: one year ] [ Designated as safety issue: No ]
    Change in functional capacity expressed as a peak oxygen uptake (VO2), that was acquired breath-by-breath by pneumotachograph (with bidirectional differential pressure) during cardiopulmonary exercize testing.
  • Change in Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up. [ Time Frame: one year ] [ Designated as safety issue: No ]

    NYHA class I: No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs, etc...

    NYHA class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

    NYHA class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest NYHA class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

Left ventricular diastolic function; functional capacity; NYHA functional class [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary end points included: 1) left ventricular diastolic function assessed by echocardiography; 2) functional capacity assessed by cardiopulmonary stress testing; and 3) NYHA functional class.
Not Provided
Not Provided
 
PUFAs and Left Ventricular Function in Heart Failure
Effects of n-3 Polyunsaturated Fatty Acids (PUFAs) on Left Ventricular Function and Functional Capacity in Patients With Dilated Cardiomyopathy

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Dilated Cardiomyopathy
  • Heart Failure
  • 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.
    Other Name: OMACOR, Pronova Biopharma, Lysaker, Norway
  • 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
    Other Name: Placebo
  • Active Comparator: n-3 PUFAs
    Intervention: Drug: n-3 PUFAs
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01223703
CS-PUFA-02
Yes
Savina Nodari, Università degli Studi di Brescia
Università degli Studi di Brescia
Not Provided
Principal Investigator: Savina Nodari, MD Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
Study Director: Livio Dei Cas, MD Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
Università degli Studi di Brescia
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP