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
  Purpose

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).


Condition Intervention Phase
Dilated Cardiomyopathy
Heart Failure
Drug: n-3 PUFAs
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of n-3 Polyunsaturated Fatty Acids (PUFAs) on Left Ventricular Function and Functional Capacity in Patients With Dilated Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Brescia:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.



Enrollment: 133
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: n-3 PUFAs 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
Placebo Comparator: Placebo 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223703

Locations
Italy
Arrhytmias and Heart failure Unit-Spedali Civili Hospital
Brescia, Italy, 25100
Sponsors and Collaborators
Università degli Studi di Brescia
Investigators
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
  More Information

No publications provided

Responsible Party: Savina Nodari, 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
ClinicalTrials.gov Identifier: NCT01223703     History of Changes
Other Study ID Numbers: CS-PUFA-02
Study First Received: October 18, 2010
Results First Received: April 11, 2011
Last Updated: January 27, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Università degli Studi di Brescia:
n-3 PUFAs
Heart Failure
Dilated cardiomyopathy
Ejection Fraction
Exercise Capacity

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Heart Failure
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014