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Completed

NCT Number: NCT01223703

PUFAs and Left Ventricular Function in Heart Failure

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arrhytmias and Heart failure Unit-Spedali Civili Hospital

Brescia, 25100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n-3 PUFAs

Drug

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 names: OMACOR, Pronova Biopharma, Lysaker, Norway

Placebo

Drug

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

Primary outcomes

  1. 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

    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 outcomes

  1. LV Diastolic Function

    Time frame: one year

    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.

  2. Functional Capacity (Change in Peak Oxygen Uptake, VO2)

    Time frame: one year

    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.

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

    Time frame: one year

    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.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study title

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

Acronym: CS-PUFA-02

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 19, 2010
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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