PUFAs and Left Ventricular Function in Heart Failure (CS-PUFA-02)
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).
Drug: n-3 PUFAs
|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|
- 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
- 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.
|Study Start Date:||November 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|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||
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223703
|Arrhytmias and Heart failure Unit-Spedali Civili Hospital|
|Brescia, Italy, 25100|
|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|