PUFAs and Left Ventricular Function in Heart Failure

Università degli Studi di Brescia133 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

133

Conditions

Dilated Cardiomyopathy Heart Failure

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.

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Arrhytmias and Heart failure Unit-Spedali Civili Hospital

Brescia, Italy

Outcomes

Primary Outcomes

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

Time frame: one year

Secondary Outcomes

LV Diastolic Function

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.

Time frame: one year

Functional Capacity (Change in Peak Oxygen Uptake, VO2)

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.

Time frame: one year

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

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.

Time frame: one year

Data from ClinicalTrials.gov

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